Medical Device Daily

Edwards Lifesciences (Irvine, California) has open-ed a new European headquarters in Nyon, Switzerland, to serve the company's growing Europe, Middle East and Africa (EMEA) operations.

On the edge of Lake Geneva, the new center supports the rapid adoption of catheter-based implantation of heart valves that saw the number of European centers practicing this less-invasive alternative to open heart surgery increased a staggering four-fold in a single year (Medical Device Daily, May 29, 2009).

Even as the first clinical studies of one-year evidence of safety and effectiveness for transcatheter aortic valve implants (TAVI) were being presented, adoption by cardiac surgeons exploded.

Where Edwards supported 30 medical centers practicing TAVI in April 2008, one year later there were 125 centers using Edwards devices. The number of implants jumped from 160 to 2,250 in the same period.

Patrick Verguet, Edwards' corporate VP for EMEA, said the new headquarters "will help us accommodate our significant regional growth in heart valves and critical care, and allow us to continue benefiting from a favorable business climate."

The company has forecast TAVI sales to double this year over 2008 reaching $100 million.

"People say there is no reward for innovation until you get to the United States, but the rapid acceptance of our products here in Europe shows a different story, and Europe is becoming a bigger piece of the Edwards' pie," CEO Mike Mussallem told Medical Device Daily.

Surgeon training in the procedure is a critical step toward greater adoption and the new Nyon center features a state-of-the-art facility where surgeon's serving as proctors teach and coach their peers in wet labs and on simulators for this delicate procedure that is indicated only for patients, typically older than 75, who are denied open-heart surgery due to co-morbidities and fragile health.

The Europe center is also expected to play a pivotal role in the roll out and continuing development of new Edwards technologies that significantly include a transfermoral delivery system for a new valve the Sapien XT.

At EuroPCR in Barcelona in May, Edwards presented the first-in-man implantations of this next-generation valve using a fourth-generation, thinner NoveFlex delivery system that narrows current catheters to the 18 Fr size required for the transfermoral route up the leg, compared to the 24 Fr thickness used for Edwards valves that are implanted transapically, or through the chest.

Sapien XT, an aortic valve with a cobalt chromium alloy balloon-expandable frame, is currently under evaluation in the PREVAIL EU trial for CE-mark approval, which is expected in 2010, according to Verguet.

CE mark for CorNova stent

CorNova (Burlington, Massachusetts) said it has received CE-mark approval for its Valecor Platinum Coronary Stent System.

The Valecor Platinum is a next-generation cobalt-chromium bare-metal stent. Utilizing a novel ion-based implantation technology called Nanofusion, the Valecor Platinum stent presents a pure platinum surface to both the lumen and artery wall to provide protection from less biocompatible components inherent in all medical-grade alloys. Platinum is known for its superior biocompatibility and biostability.

In addition, the company said its new stent offers some of the thinnest struts available and a novel open cell design that maximizes flexibility and conformability, while causing minimal inflammation and tissue damage during deployment.

"The Valecor Platinum Coronary Stent System represents a major advancement over current offerings in the relatively undifferentiated $1 billion bare stent market," said S. Eric Ryan, MD, chairman/CEO of CorNova. "Because of its highly biocompatible platinum surface and its novel open cell design, it has shown superior anti-restentotic performance compared to leading bare metal stents in preclinical studies."

CorNova is a developer of next-generation endovascular products designed to integrate new technologies into existing products and procedures, resulting in better patient outcomes without added procedure time, cost and patient risk.

The company's FiberHalo stent deployment and post-dilatation angioplasty balloon catheters are designed to provide stent lumen area measurement within the angioplasty catheter itself. CorNova also is developing a pre-dilatation version of the FiberHalo catheter that can detect the potential of mechanical failure that would allow for treatment prior to stent placement.

Spanish distribution deal for SpectraScience

SpectraScience (San Diego) reported that it has established a distribution partnership in the Spanish market through SIM (Madrid), a firm specializing in the marketing and distribution of innovative medical devices.

Michel Vaudry, SpectraScience's VP of sales and marketing, said, "We are pleased to add another distribution partner in Europe. SIM is a respected and well-established medical distribution company and adding the WavSTAT Optical Biopsy System to their portfolio is a strong validation of the need for our technology. SIM was established in 2000 and distributes other leading gastroenterological diagnostic products from market leaders including Pentax and ERBE."