A Medical Device Daily

W.L. Gore & Associates (Flagstaff, Arizona) reported receipt of the CE mark for its Gore Viabahn Endoprosthesis with Propaten Bioactive Surface in the European Union.

The device combines Gore's propriety heparin surface with the proven performance of the Gore Viabahn Endoprosthesis for the treatment of arterial vascular disease. The Gore Viabahn Endoprosthesis with Propaten Bioactive Surface is indicated for the endovascular grafting of peripheral arteries.

The device uses end-point covalent bonding to keep the heparin anchored to the endoprosthesis surface over time. The company's end-point surface attachment technology preserves the heparin bioactive sites such that they remain free to interact with the blood without being consumed.

"Gore is excited to provide the clinical community in Europe with the same proven heparin bonded surface technology for patients suffering from peripheral arterial vascular disease that clinicians in the U.S. have been using to treat occlusive disease in the superficial femoral artery for the past 18 months," said Ben Beckstead, PhD, product specialist with the Gore Medical Products division's peripheral vascular business.

The product, which comes in 5 mm to 8 mm sizes, is available with a low-profile delivery system that Gore said gives interventionalists a more streamlined approach to re-line the peripheral arteries. The endoprosthesis is constructed with a durable, reinforced, biocompatible, ePTFE liner attached to an external nitinol stent structure.

The company said the "excellent flexibility" of the endoprosthesis "enables it to better traverse tortuous areas of the superficial femoral artery and conform more closely to the complex anatomy of the artery."

GE in distribution partnership with Cytori

Cytori Therapeutics (San Diego) reported the formation of a partnership with GE Healthcare (Chalfont St. Giles, UK) to commercialize Cytori's Celution System in select European countries.

The Celution System is a European-approved cell-processing device that extracts and makes a dose of a patient's own adipose tissue-derived adult stem and regenerative cells available at the point of care.

As part of the new relationship, GE Healthcare will commercialize the Celution System in the areas of cosmetic and reconstructive surgery, translational medicine, and stem cell banking in combination with Cytori's StemSource Cell Bank product.

Cytori CEO Christopher Calhoun, CEO for Cytori, said, "GE Healthcare will immediately broaden our access to customers in Europe and should greatly expand our Celution System installed base. We will benefit from their existing hospital relationships and their established regenerative medicine sales infrastructure in countries where we currently do not commercialize the Celution System."

He added, "Ultimately, our mutual goal is to broaden the relationship after we are able to better assess the market opportunities across several therapeutic indications and geographic regions."

Sarah Bork, director of GE's Cell Technologies Program, said, "Adipose tissue is emerging as one of the leading sources for adult stem and regenerative cells, and Cytori's Celution System can provide patients' own cells at the bedside. Its quality and ease-of-use, coupled with the demand from hospitals and surgeons for cells, underscore the growth potential of this system in regenerative medicine."

The partnership provides GE Healthcare with exclusive commercialization rights for 18 months in the UK, France, Germany, Norway, Finland, Denmark, Sweden, Austria, and Switzerland for the cosmetic and reconstructive surgery market, translational medicine, and stem cell banking. The same terms apply in Belgium, the Netherlands and Luxembourg for translational medicine and stem cell banking.

GE Healthcare also has been granted a two-year right of first refusal to sales and distribution rights in all remaining European countries and the U.S.

€1.25 million investment in RevaHealth.com

RevaHealth.com(Dublin, Ireland) has received a €1.25 million investment, led by Mianach Venture Capital and supported by Enterprise Ireland.

Mianach Venture Capital has been a supporter of RevaHealth.com since its founding in 2006. Enterprise Ireland said it is investing in RevaHealth.com as a "High Performance Start Up" company for 2008, in recognition of its rapid growth rate and the success of its business model.

RevaHealth.com said it will use the €1.25 million to continue the expansion of its health clinic search engine. Originally focused on niche healthcare markets, RevaHealth.com is now expanding into wider local and national healthcare markets and plans to move into the Far Eastern and American markets later in 2009.

"More consumers are going online to research their healthcare options. RevaHealth.com provides a valuable service that gives consumers an easy way to find and compare health clinics worldwide," said Caelen King, founder/CEO of RevaHealth.com. "We now intend to take our proven business model to a wider market."

RevaHealth.com helps users find and compare health clinics worldwide. It currently stores information on more than 60,000 clinics in the UK, Ireland and 50 other countries worldwide.