A Medical Device Daily

Sorin Group (Milan) reported receiving CE marking for its new Cobalt Chrome coronary carbostent, the Chrono stent. The company said that Chrono will be “fully released“ in Europe and all the CE mark countries.

Sorin said that since its recent introduction as a new material for coronary stents, Cobalt Chrome has demonstrated “excellent characteristics including higher mechanical strength and radiopacity than stainless steel.“ It said that its advantages are enhanced by a stent design engineered to provide more flexibility and a new delivery system, Progressive Transition System, which ensures reliable access to distal and tortuous anatomies.

The stent also features two radiopaque markers at each end of the stent to guarantee accurate placement at the target lesion. Chrono is coated with Carbofilm, a proprietary coating that has demonstrated improved hemo- and bio-compatibility of the stent and to reduce stent thrombosis in a number of registries and randomized trials.

Sorin said the Chrono features extremely thin struts and the lowest crossing profile, providing flexibility without compromising radial strength and a new tapered tip giving excellent crossability.

The company said that the first implants in Europe have demonstrated the benefits of the Chrono in the treatment of complex and distal anatomies.

The Chrono “has shown excellent procedural performance even in complex and challenging lesions, where deliverability is a main issue“ said Professor Bartorelli of Centro Cardiologico (Monzino, Milan).

“Chrono is the only Cobalt chrome stent combining the proven and long term clinical benefits from Carbofilm coating platform, with superior flexibility, precise positioning and best in class deliverability, designed to redefining performance of Cobalt Chrome stents,“ said Stefano Di Lullo, president, Vascular Therapy.

Sorin Group is a leader in the development of medical technologies for cardiac surgery, interventional cardiology and the treatment of chronic kidney diseases.

CE mark sought for VScan HIV test kit

Medical Services International (MSI; Edmonton, Alberta) reported that it is beginning the procedure to obtain CE marking of its VScan HIV test kit in Europe.

The company said it has agreed to a proposal from a European pharmaceutical firm that has agreed to pay the costs for approval of the VScan HIV test kit in Europe. As part of the certification the company will look after submission of all data required by regulatory authorities, attend all necessary meetings with regulatory authorities and complete any and all other procedures required to obtain certification.

The VScan rapid test kit is a single use, disposable test for the screening of HIV 1&2, hepatitis B&C, tuberculosis, Dengue fever, West Nile, syphilis, malaria and prostate cancer.

MSI said that market studies indicate a need for more than six to eight million HIV rapid test kits in Europe annually. It said that winning the CE mark should result in sales of 2 to 3 million kits per year. The kits cannot be sold in Canada.

Lion completes bioinformatics unit sale

Lion bioscience (Heidelberg, Germany) reported completing the sale of its bioinformatics business to BioWisdom (Cambridge, UK) for up to EUR 4 million. The sales price consists of a fixed and variable payment, the latter based on business development over the next 12 months.

As a result of this transaction, Lion said it has achieved a major milestone in its restructuring plans, commenced over a year ago. “We have achieved a satisfactory result through this disposal. All obligations resulting from the bioinformatics business have been assigned to the buyer, therefore, we can now focus on the future business, based on a clean and strengthened position,“ said CFO Peter Willinger.

The bioinformatics unit, comprising the 100%-owned subsidiaries, Lion Bioscience Ltd. (Cambridge, UK) and LBAV (Cambridge, Massachusetts), will be taken over by BioWisdom, a company specializing in providing healthcare intelligence to the pharma and biotech industry.

In connection with the sale of the bioinformatics business, the planned reduction of the management board, approved by the shareholders' meeting in March 2005, has taken place, with Dr. Thure Etzold resigning as CEO. Peter Willinger will be the sole member of the management board.

“The disposal of the bioinformatics business was a primary precondition for the future strategy of Lion and its position in the market,“ said Willinger. “Lion is currently reviewing potential promising options within the life science business.“

KCI, Paul Hartmann in patent appeal withdrawal

Kinetic Concepts (KCI; San Antonio) reported that it has reached agreement with Paul Hartmann (Heidenheim, Germany) for the withdrawal of the patent appeal pending before the European Patent Office Board of Appeals involving a Vacuum Assisted Closure (V.A.C.) – an advanced wound closure system – patent licensed to KCI by Wake Forest University (Winstom-Salem, North Carolina).

The parties have agreed to enter into various agreements embodying the cooperation. In the event that the parties cannot reach one or more definitive agreements on the strategic relationships, KCI has agreed to pay Hartmann up to $2.25 million.

The patent opposition proceedings have been terminated and the EPO's 2004 decision upholding and construing the patent will remain in place. The EPO's 2004 decision established a range of pressures covered by the patent claims from 7.6 to 752 millimeters of mercury (mmHg) of negative pressure and provided that the “screen means“ term describing the dressing is an open-cell polymer foam. V.A.C. systems typically operate between 50 and 200 mmHg of negative pressure, with a default setting of 125 mmHg.

KCI and Hartmann also entered an agreement for the distribution and rental of KCI's V.A.C. line of products in Eastern Europe and for the co-promotion of V.A.C. products in the Swiss and German home care markets.

KCI is a global developer of advanced wound care systems. Paul Hartmann makes products for such areas as hygiene, incontinence care and wound care.