Medtronic Inc. (NYSE:MDT) announced Tuesday that its CoreValve System, designed to enable the replacement of a diseased aortic valve without open heart surgery, showed health improvements over a two-year period on patients implanted with the device. The CoreValve device won CE Mark approval in 2007.
The two-year study involved 126 patients at nine centers in Europe and Canada. The Fridley, Minn. company released the data at EuroPCR in Paris, France, an annual event that highlights the latest techniques, updates and breakthroughs in cardiovascular science.
Patients reported reduction in pain, discomfort, anxiety and depression, along with other quality-of-life improvements after three, six, 12 and 24 months following the procedure. The quality-of-life data is the largest regarding CoreValve’s performance and also longest-term data available from all transcatheter aortic valve implantation systems.
“… These results offer clear, mounting evidence that CoreValve is a truly transformational therapy for many patients with severe aortic stenosis, resulting in sustained clinical benefits and improved quality of life,” said Dr. Raoul Bonan, professor of medicine and interventional cardiology at Montreal Heart Institute.
While CoreValve is already being sold in Europe, it is only approved for investigational purposes in the U.S. where the product has not been immune from controversy. After Medtronic bought CoreValve in 2009 for $700 million, it inherited a patent infringement lawsuit charged by Edwards LifeSciences Corp. (NYSE:EW). The company’s name also came up in a lawsuit brought by a Mass. doctor against his employer. Dr. David Gossman of the Lahey Clinic Hospital alleged that he was fired because he resisted pressure to use Medtronic stents in exchange for the clinic’s ability to participate in CoreValve trials. At the time, a Medtronic spokesman said that a clinic’s participation in CoreValve trial is independent of the company’s commercial interests.
Medtronic began a U.S. pivotal study of CoreValve in its third fiscal quarter of 2011, which began in November 2010. In the past, Medtronic has said that its CoreValve revenue from international operations “continues to nearly double year-over-year and our share remained stable at approximately 50 percent.”
