A BB&T

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 is currently the only company to sell both transfemoral and transapical transcatheter aortic valve systems. Last month, 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.

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. 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.

VUCCC files patent for Type I diabetes treatment

VUCCC P/L (Zurich, Switzerland) last month said it has filed for patent protection of its new treatment regimen for Type 1 insulin-dependent diabetes through the European Patent Office.

The technology was developed with science emanating from collaborators at four European universities: Tübingen University (Tübingen, Germany); Heidelberg University (Heidelberg, Germany); the University of Manchester (Manchester, UK), and Uppsala University (Uppsala, Sweden). It is the result of more than a decade of clinical trial work with more than 15,000 patients, carried out in conjunction with the German Ministry of Health and other partners, the company said.

The treatment regimen is closely controlled in conjunction with the patient's doctor, guided by diagnostic testing proprietary to VUCCC. This development will see VUCCC establish diagnostic reference centers across Europe, to ascertain patients' potential treatment outcomes. VUCCC also said it would establish a centralized teaching center, for controlling the standard of the ongoing testing program.

The company estimated there would be an average long term saving to the German Ministry of Health of e70 billion a year. The estimate is based on existing costs of patient management and the number of patients treatable with this technology.

VUCCC said it would have an agreement in place with a major pharmaceutical company and an international laboratory network for marketing, distribution, sales and related laboratory services for the treatment. It will be launched in Germany this year, the company noted. Release in other countries will follow.

The company said this development represents the next step in two years of commercialization work between VUCCC and P+S Business Advisory, a division of P+S Business Brokers (Melbourne, Australia), in bringing this technology to market. Further patents are pending, the company noted.

KCI V.A.C. therapy wins reimbursement in Japan

Kinetic Concepts (San Antonio) has received reimbursement approval from Japan's Health Insurance Bureau for use of the V.A.C. ATS Therapy System in the country. The approval signifies an important advancement in the company's plans for market launch this month and follows Japan's Ministry of Health, Labor and Welfare's decision in November to grant final regulatory approval for the product, the company said.

The decision provides reimbursement coverage to physicians and hospitals for using the V.A.C. ATS Therapy System on patients suffering from severe wounds. V.A.C. Therapy, a product of KCI's Active Healing Solutions division, promotes wound healing through negative pressure wound therapy.

PPD opens research facility in Ireland

PPD (Wilmington, North Carolina) said last month it has officially opened its contract research facility in Athlone, Ireland, which includes an 18,000-square-foot analytical testing laboratory and clinical supplies business. The company said the facility expands the company's global scientific expertise, laboratory capacity and supplies network to meet growing client demand in Europe, Middle East and Africa for these services.

PPD will offer fully integrated product and analytical development services, including method development; validation; stability, release and quality control testing; and global clinical supplies services, including secondary packing, labeling and storage. The facility will also provide regulatory services, product licensing and marketed product support, including qualified person services for all drug dosage forms, with particular emphasis on inhalation and biopharmaceutical products.

The facility represents PPD's initial investment toward continued growth of its contract research operations in Ireland, having already expanded its medical communications safety call center operations into Athlone, the company said.

PPD has already hired 21 employees in Athlone and plans to create approximately 250 jobs at the laboratory to include Ph.D.-level scientists, analytical laboratory staff and other clinical development professionals.

Replication wins CE mark for GelFix

Replication Medical (Cranbury, New Jersey) said last month it has received a CE mark for its GelFix Posterior Spinal Distraction implant.

The GelFix device is a one-piece posterior spinal implant made from HPAN, a biocompatible hydrogel which exhibits desirable mechanical properties including compressive resistance with a dynamic response. The GelFix distraction implant is used as a spacer between the spinous processes to provide separation and prevent nerve pinching. The product is available in three sizes to fit the typical range of spinal stenosis patients, the company noted.

The CE mark for this implant follows the approval the company received last year from the FDA to market its EnGuard Vessel Guard. The EnGuard device is indicated for use as a protective cover for blood vessels following anterior spine surgery and is composed of the same biocompatible polymer.

Stentys stent gets CE mark for ACS

Stentys (Paris) said last month it has received the CE mark for its self-expanding and disconnectable stent to treat acute coronary syndrome (ACS).

The self-expanding feature of the Stentys platform is designed to ensure optimal apposition of a stent in the critical initial hours and days after an acute myocardial infarction (AMI) procedure, by being continuously applied to the vessel's internal surface even during thrombus and vessel spasm relief-thereby avoiding malapposition, a significant concern to cardiologists.

“For European regulatory approval we have demonstrated how the Stentys stent perfectly conforms to a variable vessel anatomy after AMI stenting,“ said Gonzague Issenmann, CEO and co-founder of Stentys. “Our strategy is to expand clinical evaluation with our APPOSITION II clinical study. This is a randomized trial comparing the Stentys self-expanding stent with a conventional balloon-expandable stent in AMI patients, using extremely high-resolution OCT (optical coherence tomography) imaging to validate endpoints.“

Study to assess WBU for breast imaging

TechniScan (Salt Lake City) reported in March that, in collaboration with University Medical Center Freiburg (Freiburg, Germany), it has launched a clinical study to assess clinical utility of TechniScan's Warm Bath Ultrasound (WBU), a system designed for ultrasound technology, used in a warm water tank, to capture 3-D images of the breast as a woman lies prone on a table.

Clinicians will scan a total of at least 150 women within three defined groups: Those with normal mammography findings, those with known benign lesions and those with known malignancies. The study includes direct comparison of TechniScan's WBU images against mammogram, MRI and hand held ultrasound to directly evaluate the ability of WBU in providing comparative diagnostic findings.

Radiologists involved in the Freiburg study will use TechniScan's imaging network which provides them with the ability to archive, store, and retrieve anonymous WBU images and relevant medical records and will discuss and compare their results with other researchers.

“Our vision is to begin to create a database of thousands of anonymous breast images and related data,“ said Dave Robinson, CEO at TechniScan. “This scientific database will consist of anonymous mammograms, breast MRIs and WBU images, along with related pathology and other information, to provide researchers around the world an unprecedented opportunity to study breast cancer.“

EC funds Smart Personal Health project

Continua Health Alliance (Beaverton, Oregon), an international organization of healthcare and technology companies, the European Telecommunications Standards Institute (ETSI; Nice, France), responsible for standardization of ICT within Europe, and Integrating the Healthcare Enterprise Europe (IHE-Europe; Brussels), reported receipt of funding from the European Commission for a 12-month project called Smart Personal Health. The project aims to promote awareness and a deeper understanding of the need for interoperability among personal health systems, devices and other e-health systems across Europe. Continua, ETSI and IHE-Europe are joined by project partners empirica (Bonn, Germany), a European research institute with a broad understanding of political, business and socio-economic issues surrounding electronic health services and telecom applications, as well as The Centre, a European expert in public affairs and event organization.

St. Jude garners CE mark for Trifecta

St. Jude Medical (St. Paul, Minnesota) said in March it 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's Linx AC Technology, an anticalcification treatment designed to reduce tissue hardening, the company said.

NxStage, Dirinco ink deal for dialysis products

NxStage Medical (Lawrence, Massachusetts) said last month it 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.

NovaStent gets CE mark for SAMBA stent

NovoStent (Mountain View, California) reported in March that it has received the CE mark for its SAMBA stent and delivery system for the treatment of peripheral artery disease. The SAMBA stent was designed to treat the highly varied presentation of atherosclerotic disease in the superficial femoral (SFA) and popliteal arteries by providing a unique combination of strength, flexibility and vessel coverage.

CE mark approval was supported by data from NovoStent's SAMBA trial, which enrolled patients in Germany last year. Lesions treated in the trial included a wide spectrum of disease such as total occlusions, eccentric calcified plaque, ulcerating lesions and thrombotic occlusions. Also included in the trial were several isolated popliteal lesions. Physicians typically avoid placing stents in the popliteal artery for fear of stent fracture, NovaStent said.

MiMedX garners CE mark for HydroFix

The MiMedx Group (Marietta, Georgia) reported in March that it received the CE mark for its HydroFix Spine Shield device and was certified for design, development, and production of post-surgical adhesion inhibiting barriers. The HydroFix is indicated for use in specific locations as a cover of the spine to provide a plane of dissection during a revision surgery. The biocompatible polyvinyl alcohol polymer membrane may reduce the risk of injury that may be associated with anterior vertebral surgeries, the company said. By covering the spine at the surgical repair site in anterior spine surgeries, HydroFix Spine Shield creates a plane of dissection for revision surgeries.

According to MimedX, the HydroFix is a permanent and biocompatible implant that is suitable as an adhesion inhibiting barrier or plane of dissection between anatomical structures.