 |
| Edwards' Intuity Elite Valve--Courtesy of Edwards Lifesciences |
Edwards Lifesciences ($EW) won a CE mark for its innovative aortic valve system. European approval for the device comes at a critical moment for the company, as it attempts to strengthen its hold on foreign markets and stay a step ahead of its competition.
Edwards' Intuity Elite Valve helps physicians make smaller incisions during aortic valve replacement (AVR) surgery. The system combines an expandable balloon frame with a pericardial platform, providing more flexibility and visibility during surgical procedures, the company said in a statement.
The company submitted data from two clinical trials in support of its valve system. Cadence-MIS, a randomized, multicenter study, compared the company's minimally invasive Intuity Valve to a conventional bioprosthetic aortic valve used during AVR procedures in 100 patients. The study found that Edwards' valve reduced ischemic time, or the amount of time blood flow to and from the heart stops during surgery, by 24%--a statistically significant number, the company said in a statement. The study also noted improved blood flow and hemodynamics in a three-month follow-up. Findings were presented at the 2014 Annual Meeting of the Society of Thoracic Surgeons.
Triton, a single-arm, multicenter prospective trial, looked at 158 patients undergoing isolated AVR and found that 55% of AVR procedures were performed using a minimally invasive valve, as opposed to a full sternotomy, Edwards said in a statement. The trial involved 6 European centers and treated a total of 287 patients between Jan. 2010 and Oct. 2012.
"We've enhanced the Edwards Intuity design to further meet the needs of patients, physicians and hospitals with a valve and procedure that can be readily incorporated into the surgeon's treatment offerings," said Donald Bobo Jr., Edwards' corporate vice president of heart valve therapy. "We believe the Edwards Intuity platform can greatly expand the population of patients who receive the less-invasive approach with important clinical and cost benefits."
It has been a busy year for the Irvine, CA-based company: Edwards recently won a battle against competitor Medtronic ($MDT) in the first head-to-head trial comparing the two companies' competing transcatheter aortic valve replacements (TAVR). An investigator-initiated study of 241 patients at 5 German hospitals found that Edwards' Sapien XT had a success rate of 95.9%, compared with 77.5% for Medtronic's self-expandable device, CoreValve. Both products are designed to replace surgery in patients with aortic stenosis--300,000 individuals worldwide, according to Bloomberg, and a market that analysts estimate at $3 billion.
But it has not all been smooth sailing for Edwards: In March, the European Patent Office revoked the company's Spenser patent for its Sapien valve, allowing Medtronic to sell its competing device in Germany. Edwards had filed a sales injunction against the Minnesota device giant in August 2013.
While it remains unclear which company will come out on top, Edwards has big plans for its Intuity valve in Europe and beyond. The valve system is part of an ongoing clinical trial in the U.S. and is commercially available at hospitals throughout Europe.
- read the release