A Medical Device Daily

Cappella (Galway, Ireland), a medical device company developing solutions for the treatment of coronary bifurcation disease, reported the start of Sideguard 3, an IVUS/OCT evaluation of the Sideguard coronary sidebranch stent and delivery system. This is a European multicenter study to evaluate the vascular response to Sideguard in de novo bifurcation lesions of native coronary arteries. The primary objective of the study is to determine the change in stent area and corresponding change in vessel area at the carina of the sidebranch during the 6-month follow-up period.

"The results from the initial CE mark pivotal studies documented positive remodelling. The Sideguard 3 study is intended to provide further certainty for those findings." said Gary Mintz, MD.

Akiko Maehara, MD, who also completed the analysis for the initial study added, "We are looking forward to having more clinical proof of the mechanisms of the remodelling process of nitinol in coronary stents." Mintz and Maehara, both affiliated with the Cardiovascular Research Foundation (New York), are the co-PIs for the study.

One of the primary German investigators in the Sideguard 3 study and pioneer in dedicated sidebranch bifurcation stenting, Karl-Eugen Hauptmann, MD, of Krankenhaus der Barmherzigen Brueder (Trier, Germany), said, "Sideguard is my stent of choice for the treatment of bifurcation lesions. I am very happy to continue my close collaboration with Cappella in this interesting clinical trial."

CleveMed receives CE mark, CMDCAS

CleveMed (Cleveland) recently received ISO 13485 certification issued by BSI Management Systems America. It has also received the CE mark and Canadian Medical Devices Conformity Assessment System (CMDCAS) allowing its products to be distributed to the large European and the Canadian markets which will strengthen its worldwide market presence.

CleveMed develops a number of telemetry-based patient monitors for sleep disorders such as sleep apnea and movement disorders including Parkinson's disease. The company claims accuracy, portability and ease-of-use allow its products to be uniquely suited to speed diagnosis and improve disease management of these disorders in emerging U.S. and international markets. These non-traditional, growing markets include the home, hospital rooms, private practices, and many others. As a leader in miniaturized wireless telemetry, physiological monitoring and rehabilitation devices CleveMed says it has been commercializing a research and education product line that is expected to benefit tremendously from international markets as well.

"CleveMed undertook the rigorous medical device certification as part of its commitment to developing products with the highest quality that fulfill un-met clinical needs for patients and providers," said Hani Kayyali, President of CleveMed. "It is a testament to our continued growth and excellence in these important medical fields."

curasan, Ben-Gurion in research accord

curasan (Kleinostheim, Germany) has signed a research and development agreement with the Ben-Gurion University of the Negev (BGU; Beersheba, Israel).

The cooperation project on which the agreement focuses is funded by the German Federal Ministry of Education and Research (BMBF) and has the ultimate goal of developing special carrier materials for the purpose of bone regeneration.

A team led by Hanna Rapaport, from the Faculty of Biotechnology at BGU, has developed and patented a new protein matrix that can significantly accelerate the process of bone regeneration. Together with curasan, BGU now intends to combine this matrix with an inorganic carrier in order to be able to manufacture a range of bone regeneration materials for orthopaedic and dental treatments.

curasan will invest 1900,000 of the 11.48 million of funding in the work being carried out by the Israeli research team. In return, curasan has been granted first rights to exclusive licensing terms for all the products resulting from the cooperation.

"The funding we have received will allow us to create a generation of new products that significantly improve bone regeneration processes while retaining the beneficial qualities of our purely inorganic, resorbable materials", said Fabian Peters, Head of Biomaterials Research and Development at curasan.