HeartWare International, Inc. (HTWR)

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10-2-11: Dr. Mark Slaughter on HVAD-vs-HMII Choice once HVAD is approved in U.S. for BTT…

10-2-2011: HeartWare Intl. EACTS/Lisbon Breakout Session
(U.S. BTT/CAP Update n=241)
Dr. Mark Slaughter (Univ.Louisville) & Heartware CEO Doug Godshall
“Results of the Heartware ADVANCE Bridge-to-Transplant Trial & CAP Update”
Webcast replay (1:28): http://edge.media-server.com/m/p/5ax6sj23/lan/en

Q&A 10-2-11 1:10:54 (question by Rajeev Jashnani/UBS on choice of HVAD-vs-HMII)
Dr. Mark Slaughter:
“(chuckle)… You’re really putting me in a bad spot here… The reason I say that is it’s actually a very complicated answer. #1, from a non-clinical point of view, hospitals are becoming very interested in the cost of the device; I was actually discussing this with Doug before we started. So, assuming that the price is equivalent, then there will little pressure on the clinicians and they will have the option to choose, assuming that the prices are fairly equivalent, which I assume they will be. To other point is, once the HVAD is approved, remember it’s only approved for BTT, so in most centers the ratio of implants for BTT vs. DT – DT is growing significantly. BTT is still an important market, but the idea is that we’ll see where it pans out in the global issue here. I think a lot of it also has to do with the overall team, and the team’s experience as to the outcomes. As an example, we were recently working with another pump and we had several bad outcomes, and I can guarantee you that we will never, ever put in another one of those pumps again, even if redesigned, because basically the coordinators and the nurses won’t allow it. So, if there is approval soon for [HVAD] BTT, and the price is equivalent, and the hospital doesn’t put any pressure on the clinicians, I think that the majority of programs, and I’ll put myself in that category, for BTT, most likely they’ll predominantly use the HVAD device. There is the perception that if you use enough of them [HVAD’s], and as the number grows that there will be some statistically significant and clinically-relevant benefits to the HVAD device.”

UBS/R.Jashnani Followup: “Pls. comment on what those advantages may be?”
Dr. Mark Slaughter (1:14:12):
”I think that the smaller size and the less surgery is important. I think that there has been a learning curve for many surgeons in learning how to de-air, getting the appropriate orientation & location, which clearly has potentially affected some adverse events. But, everybody’s getting better, more knowledgeable, and they share experiences. The less surgery, the less blood use; less time in the hospital is going to become a significant issue for the device. Already there is a difference in GI Bleeding, and I’m sure the Heartmate II will get a little bit better, but there is some inherent difference in flow patterns, centrifugal flow - right out of the bat, there is a difference, that will become a big deal, because it’s quite a nuisance for patients and certainly affects their quality-of-life, whether it’s BTT or DT. I think that in another year, people will have a much better handle on who needs coumadin and how much, and who needs aspirin. You know, everybody just assumes it spins and it pumps blood, so we’ll just do it the same, and it’s not. It [the HVAD] has its own identity, and I think people are starting to slowly starting to identify what those characteristics are, and I’m fairly certain that hemorrhagic strokes will come down; they won’t go away completely, but they’ll be minimal. And, ischemic strokes will predominantly go away. The other big issue though, thinking ahead, is that the external components need further miniaturization, because once the pump’s in & working well, the only thing the patient is concerned about is the system controller and the batteries. As I showed in the slides, even here for BTT, avg. duration on device is now over 300 days; this isn’t just short or mid-term support, and these are relatively young people. There are going to be more women, and the idea is you want them to be happy. So, addl. investment for improvements in the external components will have a huge impact on future choice as well.”

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Note: Dr. Mark Slaughter is Professor & Chief of the Division of Thoracic & Cardiovascular Surgery and Director of the Mechanical Assist Device & Heart Transplant Program at the University of Louisville.

10-2-11: EACTS/Lisbon Breakout Session – Dr. Slaughter’s Slideshow (32 slides)
. . . http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67611674

10-2-11/PR: HVAD/BTT Data Update given by Dr. Mark Slaughter (Univ.Louisville)
. . . http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67606997

9-29-11 Canaccord reits BUY in prep. for Oct2 EACTS
. . . http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67522757

10-3-11: Canaccord Reits. BUY on Heartware (PT=101); Positive HVAD Data at EACTS
. . . http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67622843