Edwards Lifesciences' TAVR Monopoly Could End Soon

Medtronic recently announced upbeat clinical results for its CoreValve transcatheter aortic valve replacement (TAVR) device that was so upbeat that FDA decided to not require an advisory panel to oversee the regulatory approval process for patients in the high-risk category. Based on the clinical data, the planned launch date of the device has been moved ahead a few months forward from the original launch date in summer of 2014. The approval would mean the end of Edwards Lifesciences' monopoly in the space, which initially approved by FDA in November of 2011 and has been the only TAVR product available since in the United States. Medtronic presented 12-month data on the CoreValve at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. According to clinical results, patients suffering from aortic stenosis who were treated with the device experienced a 25.5% rate of major stroke or death. In comparison, standard therapy for this condition yields a major stroke or death rate of 43%. For high-risk patients who received CoreValve treatment, the risk of a major stroke was only 1.8%.FDA regulators will evaluate the safety and efficacy of the CoreValve system for low-risk patients through a separate process than for high-risk patients. For Edwards Lifesciences, an early launch of the CoreValve would not be welcome news. The company's stock has recently fallen significantly from nearly $80 per share last week. In midday trading on October 30, the stock was trading close to $66. Edwards' Sapien achieved limited coverage from Medicare largely as a result of a high perioperative complication rate of ischemic strokes and femoral artery complications. The CoreValve may help address the stroke problem. "The fact that nearly three-quarters of patients [treated with the CoreValve] were alive and free of strokes at one year is remarkable, given the complex medical conditions and extreme frailty of this population," noted one researcher involved in the clinical trial. "Not only do the results meet the CoreValve study's safety and efficacy endpoints for patients at extreme risk for surgery, but the positive clinical outcomes and low complication rates set a high standard for what transcatheter valves can achieve." In related news, the Boston Scientific Lotus valve recently won the CE Mark.