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6. IDEAL Biostent: The IDEAL BioStent (Xenogenics Corp, Canton, Massachusetts, USA), a balloon expandable scaffold, is synthesised entirely from salicylic acid bioabsorbable polymer derivates. The backbone which provides mechanical support is comprised of polylactide anhydride mixed and a trimer of two salicylic acid molecules joined by a sebacic acid as a linker molecule. The backbone is coated with salicylate (a trimer of two salicylic acid molecules joined by adipic acid as a linker molecule) which controls release of anti-proliferative drug, sirolimus (8.3µg/mm) [50]. The stent elutes approximately 10µg of salicylic acid. Thus, the scaffold has both anti-inflammatory and anti-proliferative properties. It takes 30-days for complete drug-elution and 9-12 months for complete biodegradation of the scaffold [50]. The stent is radiopaque and 8-French guiding catheter compatible.
WHISPER study, a prospective FIM trial of IDEAL Biostent, enrolled 11 patients. Coronary angiography and IVUS analysis showed absence of scaffold recoil [51]. However, IVUS and OCT showed negligible neointimal suppression and a significant reduction in lumen area, which were attributed to the inadequate drug dose and fast drug elution. Hence, the new-generation IDEAL BioStent with higher drug dose, slower drug release kinetics, improved stent design with thin struts and a 6-French compatible delivery system has been designed which is currently undergoing pre-clinical evaluation
Check out the date read the part about the Ideal biostent and how they are preferable to older thicker walled stents. Says this type have no adverse affects. Like older stents.
read for your self.
Bioresorbable Scaffolds: The New Tool in PCI
Sep 19, 2016 | Vivian G. Ng; Alexandra J. Lansky, M.D., FACC Expert Analysis
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Coronary Artery Disease and Durable Metallic Stents
Coronary artery disease (CAD) is the leading cause of death among all forms of heart disease and accounts for one in every five deaths in the United States.1 Given the profound impact of CAD-related morbidity and mortality, the development of improved therapies for CAD is critical. Coronary artery stenting is now an established therapy for patients with obstructive CAD ranging from stable angina to acute coronary syndromes. Clinical trials have demonstrated that drug-eluting stents (DES) significantly reduced in-stent restenosis and target lesion revascularization compared with bare-metal stents (BMS).2,3 However, conerns remain about the risk of late and very late stent thrombosis after DES implantation, which can result from delayed stent endothelialization as well as hypersensitivity reactions to the durable polymers employed in drug delivery, leading to poor intimal healing and providing a substrate for stent thrombosis.4 Furthermore, DES leave a permanent metal implant in the coronary vessel wall that could interfere with vasomotion, endothelial function, and vessel remodeling. Although the rigid structure of BMS and DES is helpful to prevent acute or threatened arterial closure after percutaneous coronary intervention (PCI), it does not allow for restoration of normal arterial function after the procedure. Additionally, when BMS or DES are placed at coronary artery bifurcations, there is a risk of side branch vessel compromise by the stent struts.
Bioresorbable Coronary Scaffolds
The limitations of current coronary metallic stent designs have triggered interest in improved stent designs using fully bioresorbable vascular scaffolds (BVS). Scaffolds are designed to provide 1) vessel support acutely to prevent acute vessel closure and 2) anti-proliferative drugs transiently to prevent neointimal hyperplasia but be completely absorbed and integrated into the vessel wall in the long term, providing several potential advantages over existing permanent DES implants, including the following:
Restoration of physiologic vasomotion
Late expansive remodeling
Reduced risk of stent thrombosis
Ability to graft scaffolded segments of coronary artery
Avoidance of problems associated with jailing side branches
Improved imaging with computed tomography or magnetic resonance imaging
In general, two major approaches to the material construction of BVS have been investigated: metallic and polymer-based. For polymer-based scaffolds, multiple polymers are available with different chemical compositions and mechanical properties including bioabsorption times. Poly-L-lactic acid (PLLA) is the most commonly used polymer in BVS given its widespread use in other clinical arenas such as sutures and biological implants. PLLA is broken down via depolymerization and hydrolysis. The smaller chains are then metabolized by phagocytes into soluble monomers that are metabolized into pyruvate. Pyruvate is able to enter the Krebs cycle and is metabolized into carbon dioxide and water.5
Metallic BVS are an appealing concept because they may be expected to have performance characteristics similar to conventional metallic stents such as profile, deliverability, and radial strength. There are two types of metallic BVS that have been attempted: iron alloys and magnesium alloys. Magnesium alloys are the most commonly used bioresorbable metallic substrate due to their biocompatibility. Given their increased initial radial strength compared with polymeric scaffolds, magnesium bioresorbable stents are able to have thinner struts. Degradation products from magnesium alloy stents are not expected to cause adverse effects given that magnesium itself has been investigated.6
Table 1: Summary of Available Bioresorbable Scaffolds
Device
(Manufacturer)
Scaffold Material
Ancillary Medicinal Substance
Strut Thickness (mcm)
Resorption Timeframe (months)
Regulatory Status
Absorb BVS 1.0
(Abbott Vascular, Santa Clara, CA)
PLLA
Everolimus
156
18-24
Discontinued
Absorb BVS 1.1
(Abbott Vascular, Santa Clara, CA)
PLLA
Everolimus
156
24-48
FDA approved, CE marked
DESolve
(Elixir Medical Corporation, Sunnyvale, CA)
PLLA
Myolimus
150
12-2
CE marked
ART PBS
(Arterial Remodeling Technologies, Paris, France)
PLLA
None
170
3-6
CE marked
REVA
(REVA Medical Inc., San Diego, CA)
Polytyrosine-derived polycarbonate
None
200
24
Discontinued
ReZolve
(REVA Medical Inc., San Diego, CA)
Polytyrosine-derived polycarbonate
Sirolimus
115-230
4-6
Investigational
ReZolve 2
(REVA Medical Inc., San Diego, CA)
Polytyrosine-derived polycarbonate
Sirolimus
115-230
4-6
Investigational
Igaki-Tamai Stent
(Kyoto Medical Planning Co., Kyoto, Japan)
PLLA
None
170
24-36
CE marked (peripheral)
XINSORB
(Shanghai Weite Biotechnology Co., Shanghai Municipality, China)
PLLA
Sirolimus
160
Not reported
Investigational
FORTITUDE
(Amaranth Medical, Inc., Mountain View, CA)
PLLA
None
150-200
3-6
Investigational
Ideal BioStent
(Xenogenics Corporation, Lincoln, RI)
PLLA
Sirolimus
200
6-9
Investigational
AMS-1
(Biotronik SE & Co. KG, Berlin, Germany)
Mg alloy
None
165
<4
Discontinued
DREAMS 1G
(Biotronik SE & Co. KG, Berlin, Germany)
Mg alloy
Paclitaxel
125
9
Investigational
DREAMS 2G
(Biotronik SE & Co. KG, Berlin, Germany)
Mg alloy
Sirolimus
150
9
Investigational
This review focuses on the data supporting the Absorb BVS (Abbott Vascular, Santa Clara, CA), which is currently the only scaffold with US Food and Drug Administration approval.
Absorb BVS
The balloon-expandable Absorb BVS is composed of PLLA with 156 mcm thick stent struts and elutes the anti-proliferative medicinal substance everolimus.7 Because the polymer is not inherently radiopaque, two platinum radiopaque markers are incorporated into the scaffold for visualization and deployment. The scaffold is mounted on the VISION RX delivery system (Abbot Vascular, Santa Clara, CA).
The Absorb BVS has undergone the largest and most extensive evaluation of the polymeric scaffolds. The ABSORB family of clinical studies has demonstrated the feasibility of delivering a BVS with struts that are thicker than conventional durable metallic scaffolds to simple coronary lesions.
Since its first implantation in 2007,8 the performance of the Absorb BVS was evaluated in the ABSORB II9 and ABSORB III trials.10 In the randomized, prospective, multicenter, single-blind ABSORB III trial, 2,008 patients with stable or unstable angina were randomly assigned to either the Absorb BVS or an everolimus-eluting cobalt chromium DES (Xience EES [Abbot Vascular, Santa Clara, CA]).7 Procedural success was high in both the Absorb BVS and Xience EES groups (94.6 vs. 96.2%, p = 0.12). In addition, 1-year target lesion failure rates (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) were noninferior for the Absorb BVS compared with the Xience EES (7.8 vs. 6.1%, p = 0.007).7 ABSORB III demonstrated no significant difference in 1-year probable/definite stent thrombosis between the Absorb BVS group and Xience EES group (1.5 vs. 0.7%, p = 0.13).7 Although the ABSORB III trial included predominantly stable patients with relatively simple coronary lesions, studies have also revealed high procedural success rates and outcomes of the Absorb BVS in more complicated lesions such as small vessels, longer lesions, and in patients with ST-segment elevation myocardial infarction.11-18 For example, in the large multicenter, real-world GHOST-EU (Gauging coronary Healing with bioresorbable Scaffolding plaTforms in EUrope) registry, 1,189 patients received 1 or more Absorb BVS, and technical success was achieved in 99.7% of patients.19 However, treatment with overlapping Absorb BVS for longer and/or complex lesions may be associated with longer procedure length and fluoroscopy time compared with conventional DES.15
An additional potential benefit of BVS is improved vessel conformability compared with rigid metallic stents, better allowing the vessel to maintain its natural shape. On implantation, the Absorb BVS has improved geometric parameters by intravascular ultrasound (IVUS) compared with durable stents and may allow for normalization of vascular compliance and geometry over time.20-22 Furthermore, because BVS do not leave a rigid structure behind after degradation, normal coronary vasomotion can be restored. Serial imaging evaluations have demonstrated the evolution of vasomotion restoration after the Absorb BVS is implanted and undergoes resorption.23-26 Using intracoronary nitrate and ergonovine injections, there was no significant vasomotion at 6 months follow-up after the Absorb BVS implantation, and there was significant vasoconstriction and vasodilation at 1 year. At 2 and 3 years, significant vasodilation was seen when only intracoronary nitrate was injected.24
Of note, because of the different mechanical properties of BVS, there is a learning curve to optimize implantation.27 Expansion of the scaffold is important because malapposition can be associated with peri-stent evagination, which has been a proposed mechanism for scaffold/stent thrombosis.28,29 Optimal lesion preparation (such as pre-dilatation with a noncompliant balloon) improves procedural and fluoroscopy time and acute results.30-32 Post-dilatation does not appear to impact procedural or clinical outcomes.
The implantation technique for the Absorb BVS is different from that of metallic DES implantation. Adequate lesion preparation is required to facilitate full scaffold expansion. The vessel should be pre-dilated with a noncomplaint balloon with the goal of achieving 20-40% residual stenosis after pre-dilatation. A second inflation is performed to confirm that the vessel is optimal for BVS. If there is no lesion waist present, then the operator can proceed with scaffold implantation. If there continues to be a waist at the lesion, then the operator should consider additional vessel prepation with either cutting balloon, rotational atherectomy, or laser. The vessel should then be sized using either IVUS or optical coherence tomography to select the appropriate scaffold size, particularly in small (<2.7 mm) vessel sizes. Because the Absorb BVS is not radiopaque, two pairs of platinum markers have been incorporated on the balloon and on the scaffold to aid with placement. The proximal scaffold marker is 1 mm from the scaffold edge, and the distal scaffold marker is 0.3 mm from the scaffold edge. It can be useful to use zoomed images and/or 30 frames per second (instead of 15 frames per second) to visualize these markers, in particular for positioning of additional scaffolds to avoid scaffold overlap. In order to deploy the scaffold, the scaffold is expanded slowly using 2 atm over 5 seconds until the scaffold is completely expanded. Once obtained, the target deployment pressure should be held for at least 30 seconds. High pressure post-dilatation should be performed to achieve <10% final residual stenosis and ensure full strut apposition; however, to avoid damaging the scaffold, the scaffold should not be post-dilated beyond its maximum expansion range. IVUS or optical coherence tomography should be used after scaffold implantation to evaluate for complete strut apposition.
Although data have supported multiple benefits of using BVS, studies have suggested some limitations with this new technology. A large meta-analysis of the ABSORB clinical studies, which included 3,738 randomized patients treated with Absorb BVS or everolimus-eluting metallic stents, demonstrated a higher risk of definite or probable stent thrombosis in patients treated with the Absorb BVS than those treated with metallic stents (odds ratio 1.99 [95% confidence interval 1.00-3.98], p = 0.05).33 Similarly, in an expanded meta-analysis that included registry and randomized data, the rate of definite or probable stent thrombosis was higher in patients treated with the Absorb BVS compared with patients treated with DES (odds ratio 2.06 [95% confidence interval 1.07-3.98]; p = 0.03).34 Thus, additional studies and long-term follow-up are required to elucidate whether these scaffolds do indeed have higher stent thrombosis rates and whether there are certain vessel characteristics associated with higher adverse event rates. For example, a post-hoc analysis of the ABSORB III trial demonstrated that there was a higher risk of stent thrombosis rate when either the Absorb BVS or DES were used in vessels with a reference diameter < 2.25 mm.35 This was a non-significant trend; nonetheless, this led to a warning on the Absorb BVS's instructions for use that implantation of this device in small vessels could increase the risk of adverse events.
Table 2: Advantages and Challenges of BVS
Advantages
Challenges
Conformable and flexible to preserve vessel geometry
Developing a scaffold with sufficient radial strength during the critical time period
Once resorbed:
No foreign material left behind
Restoration of functional endothelial coverage
Allows the restoration of physiological vasomotion
Avoids jailing of side branches or overhanging at ostial lesions
Allows to graft stented segments of coronary artery
Visualization of the scaffold for implantation
Deliverability of the devices
Summary and Conclusions
BVS technology has evolved significantly over the last decade, and multiple clinical trials are currently investigating the efficacy and performance of BVS. The largest clinical trial to date for BVS, ABSORB III, has clearly demonstrated the feasibility of this technology. Nonetheless, there are still limitations that need to be overcome. Current limitations of BVS include ensuring adequate radial support36 and deliverability. In order to provide adequate radial support, polymeric scaffolds have thicker struts (150-250 mcm) than metallic stents (80 mcm). Furthermore, there are challenges with crimping the polymeric scaffolds onto balloon delivery systems, resulting in overall larger crossing profiles of scaffolds (1.4-1.8 mm) compared with DES (approximately 1.0 mm). As a result, scaffolds have largely been used in simple lesions, and delivery to complex and tortuous lesions may be technically challenging. Additionally, polymeric scaffolds made with PLLA are not inherently radiopaque and cannot be seen by fluoroscopy, making accurate delivery/deployment more difficult. Therefore, continued advancements in BVS technology are necessary to provide the maximum benefit to patients with CAD. In addition, long-term safety and efficacy data are still needed for this technology.
References
Lloyd-Jones D, Adams R, Carnethon M, et al. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2009;119:480-6.
Sousa JE, Costa MA, Abizaid AC, et al. Sustained suppression of neointimal proliferation by sirolimus-eluting stents: one-year angiographic and intravascular ultrasound follow-up. Circulation 2001;104:2007-11.
Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773-80.
Nebeker JR, Virmani R, Bennett CL, et al. Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project. J Am Coll Cardiol 2006;47:175-81.
Onuma Y, Serruys PW. Bioresorbable scaffold: the advent of a new era in percutaneous coronary and peripheral revascularization? Circulation 2011;123:779-97.
Kitabata H, Waksman R, Warnack B. Bioresorbable metal scaffold for cardiovascular application: current knowledge and future perspectives. Cardiovasc Revasc Med 2014;15:109-16.
Ellis SG, Kereiakes DJ, Metzger DC, et al. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med 2015;373:1905-15.
Ormiston JA, Webster MW, Armstrong G. First-in-human implantation of a fully bioabsorbable drug-eluting stent: the BVS poly-L-lactic acid everolimus-eluting coronary stent. Catheter Cardiovasc Interv 2007;69:128-31.
Diletti R, Serruys PW, Farooq V, et al. ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design. Am Heart J 2012;164:654-63.
Kereiakes DJ, Ellis SG, Popma JJ, et al. Evaluation of a fully bioresorbable vascular scaffold in patients with coronary artery disease: design of and rationale for the ABSORB III randomized trial. Am Heart J 2015;170:641-651.e3.
Ielasi A, Cortese B, Varricchio A, et al. Immediate and midterm outcomes following primary PCI with bioresorbable vascular scaffold implantation in patients with ST-segment myocardial infarction: insights from the multicentre "Registro ABSORB Italiano" (RAI registry). EuroIntervention 2015;11:157-62.
Simsek C, Magro M, Onuma Y, et al. Procedural and clinical outcomes of the Absorb everolimus-eluting bioresorbable vascular scaffold: one-month results of the Bioresorbable vascular Scaffold Evaluated At Rotterdam Cardiology Hospitals (B-SEARCH). EuroIntervention 2014;10:236-40.
Diletti R, Farooq V, Girasis C, et al. Clinical and intravascular imaging outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSORB cohort B trial. Heart 2013;99:98-105.
Diletti R, Onuma Y, Farooq V, et al. 6-month clinical outcomes following implantation of the bioresorbable everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5 mm. J Am Coll Cardiol 2011;58:258-64.
Biscaglia S, Ugo F, Ielasi A, et al. Bioresorbable Scaffold vs. Second Generation Drug Eluting Stent in Long Coronary Lesions requiring Overlap: A Propensity-Matched Comparison (the UNDERDOGS study). Int J Cardiol 2016;208:40-5.
Kraak RP, Hassell ME, Grundeken MJ, et al. Initial experience and clinical evaluation of the Absorb bioresorbable vascular scaffold (BVS) in real-world practice: the AMC Single Centre Real World PCI Registry. EuroIntervention 2015;10:1160-8.
Cortese B, Ielasi A, Romagnoli E, et al. Clinical Comparison With Short-Term Follow-Up of Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Stent in Primary Percutaneous Coronary Interventions. Am J Cardiol 2015;116:705-10.
Cortese B, Ielasi A, Varricchio A, et al. Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb™ BVS: study design. Cardiovasc Revasc Med 2015;16:340-3.
Capodanno D, Gori T, Nef H, et al. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention 2015;10:1144-53.
Brugaletta S, Gomez-Lara J, Diletti R, et al. Comparison of in vivo eccentricity and symmetry indices between metallic stents and bioresorbable vascular scaffolds: insights from the ABSORB and SPIRIT trials. Catheter Cardiovasc Interv 2012;79:219-28.
Brugaletta S, Gogas BD, Garcia-Garcia HM, et al. Vascular compliance changes of the coronary vessel wall after bioresorbable vascular scaffold implantation in the treated and adjacent segments. Circ J 2012;76:1616-23.
Gomez-Lara J, Brugaletta S, Farooq V, et al. Angiographic geometric changes of the lumen arterial wall after bioresorbable vascular scaffolds and metallic platform stents at 1-year follow-up. JACC Cardiovasc Interv 2011;4:789-99.
Brugaletta S, Heo JH, Garcia-Garcia HM, et al. Endothelial-dependent vasomotion in a coronary segment treated by ABSORB everolimus-eluting bioresorbable vascular scaffold system is related to plaque composition at the time of bioresorption of the polymer: indirect finding of vascular reparative therapy? Eur Heart J 2012;33:1325-33.
Serruys PW, Onuma Y, Garcia-Garcia HM, et al. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention 2014;9:1271-84.
Sarno G, Bruining N, Onuma Y, et al. Morphological and functional evaluation of the bioresorption of the bioresorbable everolimus-eluting vascular scaffold using IVUS, echogenicity and vasomotion testing at two year follow-up: a patient level insight into the ABSORB A clinical trial. Int J Cardiovasc Imaging 2012;28:51-8.
Simsek C, Karanasos A, Magro M, et al. Long-term invasive follow-up of the everolimus-eluting bioresorbable vascular scaffold: five-year results of multiple invasive imaging modalities. EuroIntervention 2016;11:996-1003.
Wiebe J, Liebetrau C, Dörr O, et al. Impact of the learning curve on procedural results and acute outcome after percutaneous coronary interventions with everolimus-eluting bioresorbable scaffolds in an all-comers population. Cardiovasc Revasc Med 2015;16:455-60.
Gori T, Jansen T, Weissner M, et al. Coronary evaginations and peri-scaffold aneurysms following implantation of bioresorbable scaffolds: incidence, outcome, and optical coherence tomography analysis of possible mechanisms. Eur Heart J 2016;37:2040-9.
Souteyrand G, Amabile N, Mangin L, et al. Mechanisms of stent thrombosis analysed by optical coherence tomography: insights from the national PESTO French registry. Eur Heart J 2016;37:1208-16.
Özel E, Tastan A, Öztürk A, Özcan EE, Uyar S, Senarslan Ö. What is better for predilatation in bioresorbable vascular scaffold implantation: a non-compliant or a compliant balloon? Anatol J Cardiol 2016;16:244-9.
De Ribamar Costa J Jr, Abizaid A, Bartorelli AL, et al. Impact of post-dilation on the acute and one-year clinical outcomes of a large cohort of patients treated solely with the Absorb Bioresorbable Vascular Scaffold. EuroIntervention 2015;11:141-8.
Danzi GB, Sesana M, Arieti M, et al. Does optimal lesion preparation reduce the amount of acute recoil of the Absorbe BVS? Insights from a real-world population. Catheter Cardiovasc Interv 2015;86:984-91.
Cassese S, Byrne RA, Ndrepepa G, et al. Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials. Lancet 2016;387:537-44.
Lipinski MJ, Escarcega RO, Baker NC, et al. Scaffold Thrombosis After Percutaneous Coronary Intervention With ABSORB Bioresorbable Vascular Scaffold: A Systematic Review and Meta-Analysis. JACC Cardiovasc Interv 2016;9:12-24.
Steinvil A, Rogers T, Torguson R, Waksman R. Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System. JACC Cardiovasc Interv 2016;9:1757-64.
Serruys PW, Ormiston JA, Onuma Y, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 2009;373:897-910.
- See more at: http://www.acc.org/latest-in-cardiology/articles/2016/09/19/07/22/bioresorbable-scaffolds#sthash.swnE6hzu.dpuf
recent clinical trials
Scaffold
Strut material
Coating material
Eluted drug
Strut thickness (µm)
Resorption (month)
Current status
Igaki-Tamai
PLLA
None
None
170
24–36
CE mark for peripheral use
AMS-1
Mg
None
None
165
<4
Discontinued
DREAMS-1
Mg
PLGA
Paclitaxel
125
9
Clinical trials
DREAMS-2
Mg
PLLA
Sirolimus
150
9
Clinical trials
Absorb BVS 1.0
PLLA
PDLLA
Everolimus
156
18–24
Discontinued
Absorb BVS 1.1
PLLA
PDLLA
Everolimus
156
24–48
CE mark
Absorb BVS-New generation
PLLA
PDLLA
Everolimus
<100
NA
NA
DeSolve
PLLA
None
Myolimus
150
12–24
CE mark
DeSolve 100
PLLA
PLLA
Novolimus
100
24
CE mark
IDEAL biostent
Polymer salicylate
Salicylate
Sirolimus
175
>12
Clinical trials
REVA
PTD-PC
None
None
200
24
Discontinued
ReZolve
PTD-PC
None
Sirolimus
115–230
4–6
Clinical trials
ReZolve2
PTD-PC
None
Sirolimus
100
48
Clinical trials
Fantom
PTD-PC
-
Sirolimus
125
36
Clinical trials
Fortitude
semicrystalline polylactide
-
None
150–200
3–6
Clinical trials
Mirage BRMS
PLLA
-
Sirolimus
125–150
14
Clinical trials
MeRes
PLLA
PDLLA
Sirolimus
100
24
Clinical trials
Xinsorb
PLLA
PDLLA
Sirolimus
160
24–36
Clinical trial
ART 18AZ
PDLLA
None
None
170
3–6
Clinical trials
Mg magnesium, PLLA poly-L-lactic acid, PDLLA poly-DL-lactic acid, BVS bioresorbable vascular scaffold
SA/AA salicylic acid/adipic acid, PTD-PC, poly-tyrosine-derived polycarbonate, CE Conformité
The Ideal BioStent
Very interesting.
www.jcdr.net/.../21915_CE(EK_OM)_F(AK)_PF1(SHAK)_PFA(AK)_PF2(PEK).pdf
6. IDEAL Biostent: The IDEAL BioStent (Xenogenics Corp,
Canton, Massachusetts, USA), a balloon expandable scaffold,
is synthesised entirely from salicylic acid bioabsorbable polymer
derivates. The backbone which provides mechanical support
is comprised of polylactide anhydride mixed and a trimer of
two salicylic acid molecules joined by a sebacic acid as a linker
molecule. The backbone is coated with salicylate (a trimer of two
salicylic acid molecules joined by adipic acid as a linker molecule)
which controls release of anti-proliferative drug, sirolimus (8.3µg/
mm) [50]. The stent elutes approximately 10µg of salicylic acid.
Thus, the scaffold has both anti-inflammatory and anti-proliferative
properties. It takes 30-days for complete drug-elution and 9-12
months for complete biodegradation of the scaffold [50]. The stent
is radiopaque and 8-French guiding catheter compatible.
WHISPER study, a prospective FIM trial of IDEAL Biostent, enrolled
11 patients. Coronary angiography and IVUS analysis showed
absence of scaffold recoil [51]. However, IVUS and OCT showed
negligible neointimal suppression and a significant reduction in
lumen area, which were attributed to the inadequate drug dose
and fast drug elution. Hence, the new-generation IDEAL BioStent
with higher drug dose, slower drug release kinetics, improved
stent design with thin struts and a 6-French compatible delivery
system has been designed which is currently undergoing preclinical
evaluation.
this is old news but is seems to be in the wind again. Be sure to read the date. It seems that things take time to develop.
Xenogenics acquires Ideal BioStent assets
Published on October 19, 2010 at 9:33 AM · No Comments
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MultiCell Technologies, Inc. (OTC Bulletin Board: MCET) and its majority owned subsidiary, Xenogenics Corporation, are pleased to announce the acquisition of the Ideal™ BioStent assets by Xenogenics Corporation from investment funds managed by Western Technology Investment and Silicon Valley Bank. Xenogenics Corporation also entered into a worldwide exclusive license with Rutgers University for rights to certain intellectual property related to the Ideal™ BioStent.
The multi-billion dollar interventional cardiology and intravascular stent market remains extremely lucrative, and one of the most attractive opportunities for medical device companies. Several analysts predict the 2010 estimated worldwide interventional cardiology and intravascular stent market to exceed $4.6 billion, growing 3% to 4% annually. Clinicians, patients and manufacturers are seeking the next generation of interventional cardiology and intravascular medical devices which address long-term safety concerns and improvement of blood vessel health, while still providing efficacy equivalent to current generation products.
The Ideal™ BioStent is the only stent to offer a dual-drug polymer, incorporating salicylate, the active component in aspirin, directly into the polymer chain. As the polymer degrades, salicylate is released directly into the vessel wall to provide anti-inflammatory therapy aimed at reducing stenosis and the promotion of blood vessel healing.
The Ideal™ BioStent also incorporates the drug Sirolimus (rapamycin) in its polymer matrix to provide anti-restenotic therapy similar to today's commonly used drug-eluting metal stents. The Ideal™ BioStent's technology allows for the ability to layer different combinations of polymers and drugs, enabling the optimization of the delivery of combination drug therapies to provide superior clinical results. The Ideal™ BioStent represents a significant advance over currently available stents, including:
The ability to promote positive vessel remodeling.
A significant reduction in late-stent thrombosis risk.
No metal artifact remaining in the patient's body after vessel healing.
The reduced need for long-term and costly anti-platelet therapy.
In extensive animal testing and initial human use, the Ideal™ BioStent demonstrated equivalence in safety, short-term efficacy and structural integrity when compared with today's leading bare metal stent and drug-eluting metal stent. Importantly, unlike other bioabsorbable stent technologies, the Ideal™ BioStent showed no stent recoil, both acute and at six month follow up, remaining well apposed to the vessel wall. Furthermore, the Ideal™ BioStent is designed to be fully absorbed at 12 months leaving no metal artifact behind in the blood vessel, and allows the blood vessel to heal and return to its natural biological state.
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The ability of the Ideal™ BioStent to leave no permanent structure behind offers several advantages over today's drug eluting and bare metal stents:
No risk of late adverse events. Because the Ideal™ BioStent eliminates the permanent implant and polymer of today's drug-eluting stents, it also eliminates the risk of late adverse events, such as late stent thrombosis. Patients will not require costly antiplatelet therapy for long durations, potentially opening the market to diabetic patients, or patients with other bleeding disorders who were previously contraindicated for stent placement.
Promotes remodeling of the artery. Permanent metal stents, because of their rigidity, prevent the artery from reacting naturally and make true healing impossible. As a result, clinician interest is accelerating around the extremely strong potential of bioabsorbable stents to promote vascular healing and return vessels to their natural state.
Does not preclude future interventions. Patients with metal stents may not be able to undergo future procedures, such as bypass surgery. Biodegradable stents do not have this limitation, and by promoting healing of the vessel wall, bioabsorbable stents may even reduce the likelihood that such future interventions will be necessary.
"We saw a significant opportunity to build upon $20 million in invested capital, since the Ideal™ BioStent has already demonstrated proof of concept in initial human clinical trials", stated W. Gerald Newmin, Chairman and Chief Executive Officer of MultiCell Technologies.
Xenogenics Corporation also licensed rights to a strong intellectual property portfolio covering the Ideal™ BioStent. This patent estate includes 24 issued patents, and over 65 patent applications with broad claims encompassing interventional cardiology and intravascular bioabsorbable stent design and manufacture.
MultiCell Technologies provided the financing for the acquisition of the Ideal™ BioStent. MultiCell Technologies increased its ownership position in Xenogenics Corporation to 91.72% as a result of providing the acquisition financing. Additional information about the transaction can be found on MultiCell Technologies' Form 8K filed with the Securities and Exchange Commission ("SEC").
It is up to you to do this I will not insult the guy in charge. Let us know what he says when you ask him. Remember I like him. I still think it is going to run this spring. If it does steaks all around that is if I can sell it at .02.
Good luck to all.
Good luck with that. I think you might just have something there.
I'm hoping for another big run this spring don't care what one might think. If you don't by now and it goes up above a penny again you can only blame yourself. If you look at the long-term chart you will see that it goes above of Penny many times back into the dust and return to the pennies. Just like the birds fly north in the summer and south in the winter. Hundred bucks get your ten thousand. Not a bad investment. Merry Christmas.
I talked to Charles about 3 weeks ago. He said he was trying to get current by the end of the year. Also working on projects. Wouldn't give any details. That's all I know from the phone call. I like the guy hope he gets R done.
I would think that you are right and this has a chance to turn it around. They have had some great partners over the years. I have only held the stock 5 years. Hoping to get to a dime before next year is over. I would like to change my own business model. Have a good holiday.
Going to be current soon.
I have owned this stock since before this fella and will own it until it has a prolonged run and not just a fat finger.
Lets see if the stock is current by years end or not before we say anything to bad about it. I know they are behind in the filings for now I am hopeful that the filings get current. If the do then other things are possible.
On the verge of a breakout I think.
You guys promised this would be over in oct 2016
You are right Braveheart. I want to see fillings get updated and the company get current before get excited. It will mean we will be more secure in our investment.
Wow that one I have not read yet.
I am a share holder, and have been here for a long time. I have done research in my twenties. It takes time to get these things done.
Good Call it is going to be a winner.
The operators got all of the companies assets that were worth a dam.
cool
could mean a great many things but there were no new shares printed this time. Maybe a Reverse Merger or Partnership agreement. Maybe there is a new license set aside. Never know but there is going to be a run when we get closer to the news I bet a little on it.
I hear that they got some funding and are going to get the filings done.
I sure hope so. It could cause a big run if there is any good news that go along with the filings.
maybe there is no promo crew. I got a 20 ct. Alexandrite in an estate and I am working on getting it certified worth more than I have ever had before if I can certify the stone. So what I am trying to say that people get busy this time of year with other things. I am still waiting for some new developments here.
nice close
Well the news yesterday came out and as always people selling news. A two-year contract with the fellow who brought us out of the Grey Sheets is good news. Looking forward to continued positive news and improving fundamentals.
It's not the end of the day yet and people always sell on news. Just relax and wait for it it will turn and go back up. Could be positive end of day.
Up trend intact. It is a running.
Here we go. Any more news comming?
up trend intact
Might get to .02 today.
There's no reason why this can't get back to a dollar.
up trend intact.
They just got them and if they were selling it would say that they were selling were sold in the 8k in a few days. Also they will have to register the restricted shares before they can sell them which takes a few weeks and I think they have to hold him for a year first maybe two depends on the guidelines of the restrictions. I don't buy restricted shares because trouble it is to get the restrictions off when you want to sell. So I would say they're not selling it's just people reacting and taking a profit based on charting.
what is the rush? This is going to take time to develop.
I like that it is to see that the management is buying stock directly.
Case you didn't understand get stuff means good day goodbye avidazen and what's the difference between an audit and an SEC investigation. Wait don't answer that they're the same thing just one last a lot longer. We're back from suspension. Maybe you should short it some more.
Yeah but you said that the stop sign up you're exaggerating. They came back from the grey sheets that means after a very rigorous audit but the feds best accountants and CPAs at the SEC they are okay find them nothing wrong. That makes this company okay by me. Get stuffed.