A Medical Device Daily

Heart valve replacement and repair, which uses minimally invasive percutaneous cardiac intervention (PCI) techniques, continues to be a disruptive surgical approach compared with traditional open cardiac surgery. And now Edwards Lifesciences (Irvine, California) may be considered the front runner among aortic valve makers since it's currently the only company to commercialize both transfemoral and transapical transcatheter aortic valve systems. Yesterday, Edwards won CE-mark approval for its Edwards Sapien XT transcatheter aortic heart valve, as well as its NovaFlex transfemoral and Ascendra 2 transapical delivery systems.

With these products, Edwards is targeting a rapidly expanding market. Transcatheter aortic valve implantations (TAVI) reported in Europe increased five-fold in 2009, jumping from 923 procedures in 2008 to more than 5,000 procedures (Medical Device Daily, May 29, 2009).

Edwards is beginning a European launch of the new valve with the 18 French NovaFlex delivery system, and will expand the number of commercial sites using the system throughout the year.

Other companies aren't far behind in efforts to deliver new PCI technologies. Last year Medtronic (Minneapolis), for example, entered this market segment with the acquisition of CoreValve (Irvine, California) for $700 million (MDD, Feb. 24, 2009). CoreValve developed the ReValving system, a transcatheter, transfemoral aortic valve replacement product designed to offer high or prohibitive surgical-risk patients an opportunity to have their aortic valves replaced using a catheter inserted through an artery in the groin. The company received CE mark approval for that system in 2007.

The Edwards Sapien XT transcatheter valve enables doctors to replace failing aortic valves without major surgery. The leaflet design of the new valve is modeled after Edwards' aortic tissue valves and its cobalt chromium frame provides improved radial strength and, therefore, enhanced circularity. The Edwards Sapien XT valve with the NovaFlex transfemoral delivery system is designed to provide easy, precise, balloon-expandable delivery of the valve.

As heart teams continue to gain clinical experience with the Edwards Sapien XT valve on the Ascendra 2 transapical delivery system, Edwards will begin introducing that system commercially in Europe during the second quarter. The Ascendra 2 system features a reduced profile and is designed for improving ease-of-use when delivering the valve through a small incision between the ribs.

The Edwards Sapien XT valve is the second commercially available transcatheter valve in the Edwards Sapien product portfolio. Both the transfemoral and transapical transcatheter aortic valve systems have been available in Europe since 2007. In the U.S., the Edwards Sapien valve is an investigational device being studied as part of a randomized, pivotal clinical trial of a transcatheter aortic valve and is not yet available commercially.

St. Jude garners CE mark for Trifecta

St. Jude Medical (St. Paul, Minnesota) has received CE-mark approval for the Trifecta valve, marking the company's launch into the market for pericardial aortic stented tissue valves.

The Trifecta tissue valve is used to replace a patient's diseased, damaged or malfunctioning aortic heart valve, which controls blood flow from the heart to the rest of the body. The valve has a tri-leaflet stented pericardial design which offers nearly unobstructed blood flow in order to mimic as closely as possible the flow of a natural, healthy heart. The valve design includes leaflets manufactured from pericardial tissue attached to the exterior of the valve stent which open more fully and efficiently to perform like a natural heart valve.

The valve's titanium stent, which provides a fatigue resistant frame to support the valve within a patient's heart, is covered with pericardial tissue to allow tissue-to-tissue contact when the leaflets open and close, which reduces the amount of wear and deterioration. Additional attributes contributing to the Trifecta valve's durability include proprietary tissue fixation and St. Jude Medical's patented Linx AC Technology, an anticalcification treatment designed to reduce tissue hardening.

Briggs earns ISO registration and CE mark

Briggs Medical Service (Waukegan, Illinois) has earned both the In ternational Organization for Standardization (ISO) Registration and the CE mark certification.

ISO awarded Briggs a certificate of registration (ISO 13485:2003) for the design, development and manufacture of obstetrics, pediatric and incontinence management products; and for the manufacture design, sale and distribution of durable and disposable medical products. The ISO registration identifies that Briggs has formalized business processes and quality management systems in place enabling it to provide a quality management system that consistently meets regulatory and customer requirements.

The CE mark certification was granted for Briggs' Mabis-branded line of obstetric products, including the Amnihook, Plastibell and U-Bag.

NxStage, Dirinco ink deal for dialysis products

NxStage Medical (Lawrence, Massachusetts) has signed a five-year distribution agreement with Dirinco (Schweiz, Switzerland) for the promotion, sale, delivery and service of certain NxStage and Medisystems products in the Netherlands.

The NxStage System One and PureFlow SL dialysate preparation system will be available to dialysis centers throughout the Netherlands exclusively through Dirinco. Dirinco will also make available the System One for use in critical care applications, and has the option to make NxStage Medisystems ButtonHole needles available to its customers in this region.

“As many dialysis patients in this region seek alternative treatments to in-center dialysis, we believe there is a real opportunity to advance home hemodialysis in the Netherlands,“ said Roel Kuiper, managing director of Dirinco.