dr. bio...
There are volumes of randomized, prospective, peer reviewed evidence supporting Cambridge Heart's spectral MTWA. There is only one prospective trial on Vicor's PD2i, which only began August 2006 and has recruit less than a dozen patients toward it's 700-900 patient goal. While 510K approval is relatively easy to get on a non invasive test with little risk (aka GE's modified moving average TWA test), CMS and insurance compensation will require MULTIPLE prospective trials in a variety of populations (Ischemic cardiomyopathy, EF < 35%, EF > 35%, etc). It is smoke and mirrors for Vicor to declare that amble evidence will be available by late 2007 or early 2008 to request CMS approval. We all know that a 700-900 multi-center RCT takes 2-3 years to fully enroll and analyze--especially when you haven't even defined the SITES that will participate. They are at least as far behind as GE, maybe further. CAMH has a defined and expanding relationship with St Jude's and growing acceptance throughout the ICD industry. Vicor is not near term competition and their obsequious press releases are intentionally vague, in my opinion, because they are trying to raise capital from underinformed investors. Feel free to visit CAMH boards on Raging bull or Investors Village for more info. Here is the info on the VITAL trial from Vicor's website.....regards....thad
THE VITAL TRIAL (or “Prospective, Multi-Center Study of the Ability of the PD2i Cardiac Analyzer to Predict Risk of VentrIcular TachyArrhythmic Events such as, Sudden Cardiac Death VentricuLar Fibrillation (VF) or Ventricular Tachycardia (VT) in High Risk Patients”)
The VITAL trial was initiated in August, 2006 and will be, conducted by Harvard Clinical Research Institute (HCRI) which is responsible for the overall coordination and monitoring of the trial. The FDA, in pre-IDE (Investigational Device Exemption) meetings, agreed to the final PD2i protocol and study design for the pivotal VITAL study. Target Health, Inc., a full service contract research organization is responsible for developing the electronic case report form to permit the gathering of patient data via the Internet, and will be responsible for preparing and submitting Vicor's Premarket Notification 510(k).
700-900 patients (MADIT-II/SCD-HeFT patient cohort)
30-60 Sites
Coordinated by the Harvard Clinical Research Institute (HCRI)
Co-Directors: Dr. Mark Josephson & Dr. Matt Reynolds
Final protocol has been approved by FDA
Site selection is underway
First patient to be enrolled by 10/31/06
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