TCT 2010: TAVI Takes Center Stage

Article preview from Medtech Insight- December 01, 2010

In the interventional cardiology community, 2010 could certainly be considered a breakthrough year for percutaneous heart valve devices. At two major US cardiology conferences: the American College of Cardiology in the spring, and most recently, the Transcatheter Cardiovascular Therapeutics symposium, held in September, impressive results from randomized trials of transcatheter heart valve replacement/repair devices set the venues abuzz and had physicians speculating about possible near-term paradigm shifts in the way heart valve disease will be treated. The big questions now are how long it will take before these devices reach the US market, and exactly how many US patients are likely to be implanted once they are available.

TCT 2010: TAVI Takes Center Stage

Article preview from Medtech Insight- December 01, 2010

In the interventional cardiology community, 2010 could certainly be considered a breakthrough year for percutaneous heart valve devices. At two major US cardiology conferences: the American College of Cardiology (ACC) in the spring, and most recently, the Transcatheter Cardiovascular Therapeutics (TCT) symposium, held in September, impressive results from randomized trials of transcatheter heart valve replacement/repair devices set the venues abuzz and had physicians speculating about possible near-term paradigm shifts in the way heart valve disease will be treated. The big questions now are how long it will take before these devices reach the US market, and exactly how many US patients are likely to be implanted once they are available, a topic that stirred considerable debate at both conferences.

At ACC, researchers presented 12-month outcomes from the randomized EVEREST II trial, which pitted Abbott Vascular Devices/Abbott Laboratories Inc.'s MitraClip percutaneous edge-to-edge mitral valve repair system against surgical valve repair or replacement. The results suggest that MitraClip repair is a safe and effective alternative to surgery in high-risk patients with significant mitral regurgitation. Based on the data, Abbott filed a Premarket Approval (PMA) submission with the US Food and Drug Administration (FDA) and hopes to launch the device in the US sometime in 2011 (the MitraClip was CE marked in Europe in March 2008). ( See "ACC 2010: Abbott's MitraClip Percutaneous Valve Technology Scores Big," Medtech Insight, April 2010 [2010400035].)

While percutaneous mitral valve repair stole the show at ACC, the hot topic of discussion at the TCT meeting was transcatheter aortic valve implantation (TAVI). TAVI generated a great deal of excitement among TCT attendees following the presentation of excellent 12-month clinical outcomes from Edwards Lifesciences Corp.'s highly anticipated pivotal PARTNER study investigating the firm's first-generation (22-24 French) Sapien balloon expandable TAVI device. ( See "Edwards: Transcatheter Valve Leader Proves You Can Go Home Again," IN VIVO , November 2010 [2010800180].)

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