Medtronic, Inc. (MDT) announced that it has received the U.S. Food and Drug Administration (:FDA) approval for its transcatheter CoreValve System. This self-expanding heart valve is implanted in patients suffering from severe aortic stenosis who are at high risk for surgery.
The approval is based on the positive results depicted by the High Risk study of the CoreValve U.S. Pivotal Trial, where the CoreValve System has shown superior clinical outcomes compared to open-heart surgery for aortic valve replacement at one year.
About the Study
A total of 747 patients, comprising almost equal numbers of men and women with an average age of 83.2 years, were enrolled in the High Risk study.
Medtronic worked closely with the FDA through the trial and the Pre-Market Approval (:PMA) review process. Subsequently, the FDA granted Priority Review Designation for both the Extreme Risk and High Risk PMA submissions.
Impressed by the extraordinary clinical outcome delivered by Medtronic in the U.S. Pivotal Trial, the FDA exempted the external Advisory Committee panels' review for the approval of the CoreValve System.
In this head-to-head study, transcatheter aortic valve replacement (:TAVR) using the CoreValve System was compared with traditional surgical aortic valve replacement. It was found that the survival rate of patients at one year receiving the CoreValve System was 85.8%, compared to 80.9% receiving a conventional surgical valve.
For patients treated with valve replacement procedure, risk of stroke is one of the most perturbing complications during surgery. The study demonstrated significantly better rate of MACCE (major adverse cardiovascular or cerebral events) for CoreValve patients at one year.
Major stroke rates in patients who received the CoreValve System were 3.9% at 30 days and 5.8% at one year, while the same for patients with surgery were 3.1% and 7%, respectively.
Moreover, overall hemodynamic (blood flow) performance was better in CoreValve patients than in surgical patients across all time points.
A small incision substitutes the need for an open heart surgery in patients receiving the CoreValve System. This, in turn, reduces potential risk of stroke and enhances the person's life term.
Facts about CoreValve
The CoreValve's self-expanding frame provides controlled deployment, enabling physicians to accurately place the valve inside a patient's original valve and helps in treating patients with difficult or small vasculature.
The FDA has approved the entire CoreValve platform - including the 23mm, 26mm, 29mm and 31mm size valves.
Medtronic plans to launch the 26 mm and 29 mm versions of CoreValve Evolut R, which is the next-generation recapturable transcatheter aortic valve implantation (:TAVI) system with a 14-French equivalent delivery system, in fiscal 2015.
The CoreValve System was approved by the FDA for patients at extreme risk in Jan 2014. Since receiving CE (Conformité Européenne) Mark in 2007, the CoreValve System has been implanted in more than 60,000 patients in above 60 countries.
Medtronic currently has a Zacks Rank #3 (Hold). Some better-ranked medical product stocks that warrant a look include Cardica Inc. (CRDC), ICU Medical, Inc. (ICUI) and NeuroMetrix Inc. (NURO). All the three stocks carry a Zacks Rank #2 (Buy).