Full article reprinted from "The Gray Sheet" - February 16, 2009
Find out how St. Jude Medical plans to begin clinical trials of a transcatheter aortic heart valve system by the end of 2010, with the goal of earning a CE mark for European marketing in mid-2012.
St. Jude Unveils Plan To Launch Transcatheter Aortic Valve By 2012
Full article reprinted from "The Gray Sheet" - February 16, 2009
St. Jude reported Feb. 6 that it is working on two versions of the system. A minimally invasive system designed to be delivered through the apex of the left ventricle is furthest along and will debut first. A version intended for delivery through the femoral artery will enter trials by the end of 2011 and earn a CE mark in mid-2013, the firm projects.
St. Jude currently offers a range of mechanical and tissue replacement heart valves and heart valve repair products. It also markets a variety of intravascular guidance and delivery devices that will complement the transcatheter valves, including large bore introducers, femoral access site closure devices and guidewires.
The company recently acquired MediGuide, which is developing the gMPS medical positioning system; the technology could be used to guide precise delivery of transcatheter valves, according to St. Jude (1"The Gray Sheet" Jan. 5, 2009, p. 7).
Company Discusses Catheter Valve Design Choice
Until its annual analyst meeting in New York on Feb. 6, St. Jude had not revealed its plans to market minimally invasive valve technology. "We've not previously disclosed our commitment to the transcatheter valve replacement market [because] we didn't want to be in the position of just arm waving and kind of talking with nothing to show," CEO Dan Starks explained at the meeting.
"We've been not talking about our program, [but] we've been very carefully watching and listening and paying very careful attention about what are the issues in this segment," St. Jude Cardiovascular President Frank Callaghan said.
"We went into this with zero bias in terms of what would be the best technology to treat these patients," Callaghan continued. The company tested both self-expanding and balloon-expandable valve designs before settling on a self-expanding stented valve made of bovine pericardium.
Both of St. Jude's transcatheter valve systems under development deploy a self-expanding, stented aortic replacement valve made of bovine pericardium, which can be implanted through a small incision instead of the sternotomy required for conventional surgical valve repair and replacement. The devices are intended to be replacements of either a native valve or a previously implanted valve that has deteriorated, Callaghan said.
St. Jude hopes to have a competitive advantage over its rivals by making its valves easier to deliver accurately, Callaghan explained. "We'd also like to see this technology transition to the point where a single operator can deploy it," the exec said. "Today, competitive technologies out there are very difficult, requiring more than two hands to deploy, and we'd like to change that."
Rivals Edwards Lifesciences (Sapien) and CoreValve (ReValving) already have CE marks for transcatheter aortic valves and are working on U.S. approval (2"The Gray Sheet" Oct. 20, 2008, p. 16).
Medtronic hopes to launch its Melody transcatheter pulmonary valve in the U.S. in 2010 and is also developing transcatheter aortic valves (3"The Gray Sheet" Nov. 17, 2008, p. 12).
St. Jude estimates that the annual market potential for transcatheter aortic valves is more than 300,000 patients worldwide - about the same number as currently undergo surgical valve replacement.
Initially, transcatheter valves are intended for patients considered to be inoperable due to one or more comorbidities. However, Callaghan predicts that transcatheter valves eventually will cannibalize the surgical aortic valve market.
"This technology is in its early stages and, of course, it's going to be limited to high-risk patients [initially, but] there certainly is an opportunity over time as procedural competence and technology improves that we might see a transition into lower-risk patients," Callaghan said. "Patients are also educated and we think that in the future patients may demand this kind of technology rather than having their chests opened."
- Reed Miller
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