A Medical Device Daily

BSI Management Systems (Reston, Virginia) has launched a new speed-to-market program for Class III medical devices needing CE-mark design dossier reviews at this week's Regulatory Affairs Professionals Society annual conference in Boston.

Named CE-45 FastTrack, the program expedites the review process in which most reviews are completed in 45 working days for medical devices headed to the European markets. The new program builds on a similar program launched last year called CE-90, in which dossier reviews are finished within 90 working days.

"There are many Notified Bodies, but the design dossier review process is not always clear and transparent to the medical device manufacturer," said Paul Brooks, vice president and country manager for BSI Product Services Healthcare. "In the final step of the launch, CE marking is the only thing standing between the manufacturer and access to over 400 million citizens in the European market, so it is a critical part of launching their product in Europe. They want the process to be predictable, thorough and fast as possible."

Brooks noted that BSI does not guarantee CE-mark certification in 45 or 90 days, but the goal is to complete the review process with either a positive or negative recommendation. Some products, such as medicinal or animal tissue products, require the use of outside agencies, so they may not be eligible for these programs.

He said BSI created the CE-45 FastTrack Program for when every moment counts in the final phase of getting medical devices to European markets, Brooks said.

He noted that BSI has recruited top industry experts to implement this new service. "We have been listening to our customers. We have been hearing what their problems, issues and expectations are, and these two services are a direct result of that. CE-90 was the first step last September to make the process more predictable and more transparent for medical device manufacturers. CE-45 is the next initiative, [and] we are working on many other initiatives."

BSI terms itself "the world's leading quality management systems registrar." It has certified more than 90,000 locations in nearly 90 countries.

French distributor for Hemotase MPH

CryoLife (Kennesaw, Georgia), a biomaterials, medical device and tissue processing company, reported that it has begun distribution in France, through Laboratoire Gamida, of Hemostase MPH for use in general, cardiac and vascular surgery.

CryoLife began distributing Hemostase MPH in the U.S., the United Kingdom and Germany in the 2Q08, and distribution in other markets is planned for later in 2008 and in 2009.

Hemostase MPH is developed using CryoLife's Microporous Polysaccharide Hemospheres technology (MPH), which yields a plant-based powder engineered to rapidly dehydrate blood, enhancing clotting on contact. This hemostatic agent facilitates the formation of a resilient, natural clot within just a few minutes.

Hemostase MPH received CE-mark approval in 2003 and FDA approval in September 2006.

Unlike many hemostatic agents, Hemostase MPH does not require additional operating room preparation or special storage conditions. The company said pre-clinical evaluations have shown that Hemostase MPH does not promote infection and absorbs within 24 to 48 hours of application at the wound site, compared to other surgical hemostats that can take three to eight weeks or more to fully break down.

"As a complement to CryoLife's BioGlue product line, Hemostase MPH gives surgeons the ability to quickly control active surgical bleeding, and we are pleased to begin offering this product in France," said Steven Anderson, president/CEO.

He said the company would showcase Hemostase MPH at the European Association of Cardiothoracic Surgeons meeting in Lisbon, Portugal, later this week.

Laser maker creates European distributor

Ellex Medical Lasers (Adelaide, Australia) reported another step in expanding its global reach with the establishment of a direct sales channel in Germany, Ellex Deutschland.

Formally launched at this week's European Society of Cataract and Refractive Surgeons (ESCRS) meeting in Berlin, Ellex Deutschland will focus initially on sales of Ellex laser products.

Ellex's distribution partner for the Eye Cubed ultrasound product in Germany, M+C GmbH, will provide administration and logistical support for the new operations, which the Australian company said would allow it to establish a strong market position with minimal investment and reduced risk.

M+C has been active in the ophthalmic market for 20 years and has distributed Ellex's Eye Cubed since 1990. Ellex said the partnership between the companies will enable them to leverage common marketing channels and contacts. Plans include joint exhibits at German trade shows, promotional campaigns and educational workshops.

Ellex noted that with more than 8,000 ophthalmologists, Germany is one of the largest ophthalmic markets in the world. "The German market has significant potential and we look forward to working directly with ophthalmic surgeons throughout the region to demonstrate the quality of our products and our commitment to service," said Ellex CEO Kevin McGuinness.

The first sales from the German operation are expected this month.

Ellex Medical Lasers manufactures a complete line of lasers and diagnostic ultrasound systems used by ophthalmologists. With more than 14,000 systems delivered to the market, it has evolved since 1985 from a company manufacturing primarily OEM products to direct marketing of its own branded products through subsidiaries in the U.S., Japan and Australia, and a network of distribution partners in more than 100 countries.