A Medical Device Daily

The Cypher Select Plus from Cordis (Miami Lakes, Florida) has become the first third-generation drug-eluting stent (DES) to receive CE mark approval. The company said it would begin launching the product in Europe in September, with full market launch by year-end.

Cordis said the enhanced stent delivery system of the new DES “offers exceptional deliverability, as well as the excellent, long-term clinical performance for which the Cypher stent is known.”

“A broad range of clinical studies has demonstrated that the Cypher stent is an effective and safe treatment for coronary artery disease,” said Philip Urban, MD, director of invasive cardiology at La Tour Hospital (Geneva, Switzerland) and the coordinating investigator of e-SELECT Registry, a global registry designed to assess the performance of the Cypher Select family of stents in daily clinical practice.

He said the Cypher Select Plus “builds on that tradition by featuring enhancements that ease the delivery of the stent to the site of a lesion.”

In addition to a flexible stent design and short tip, Cordis said the new DES features the Cyph2onic hydrophilic coating technology, which it said is “significantly more lubricious than previous Cypher stent products, greatly increasing a physician's ability to successfully navigate challenging coronary arteries.”

Dennis Donohoe, MD, vice president of worldwide clinical and regulatory affairs for Cordis, said physicians “will experience unprecedented ease in the delivery” of the new stent.

The company said it is “aggressively building” its manufacturing capacity for the Cypher Select Plus launch. It said it is “committed to ensure that physicians have ready access to the product as it becomes available in various countries outside the U.S.”

Cordis introduced the first second-generation drug-eluting stent, the Cypher Select, outside the U.S. in 2004. The Cypher stent is available in more than 80 countries.

Tm signs Dutch distributor for RVP

Tm Bioscience (Toronto), a developer of genetic tests, said it has signed a distribution agreement with Sanbio to commercialize the company's ID-Tag Respiratory Viral Panel (RVP) in the Netherlands. The ID-Tag RVP detects and discriminates between 20 respiratory viruses, including avian flu and sudden acute respiratory syndrome (SARS).

“Signing our first European distribution agreement for our ID-Tag RVP is an important milestone in our global commercialization strategy for this product,” said Greg Hines, president and CEO of Tm Bioscience. He said the company intends to complete a series of distribution agreements across Europe over the coming months to be positioned for the rapid commercialization of the test upon gaining European regulatory clearance, which Tm anticipates achieving yet this year.

The company said the ID-Tag Respiratory Viral Panel is a molecular diagnostic test that has the potential to play a key role in the diagnosis of respiratory viruses in clinical settings in addition to its role as a tool to assist in managing the pandemic threat of avian flu. Tm Bioscience's strategy is to make the ID-Tag RVP product a worldwide standard for use in patient and resource management in clinical environments as well as for use in public health programs.

Sanbio is a leading distribution company based in the Netherlands which supplies products for research and diagnostics in the Benelux countries (Belgium, the Netherlands and Luxemburg) to universities, research institutes, pharmaceutical and biotech companies. It also develops and manufactures a broad line of monoclonal antibodies under its own brand name, Monosan, which are sold through worldwide distribution on network.

Tm Bioscience expects that the ID-Tag RVP will address two key markets – first as a cornerstone diagnostic product in the clinical setting for the more efficient management and treatment of patients who may be infected by respiratory viruses, and also in managing potential pandemic threats via adoption by the global public health community.

Tm Bioscience is a DNA-based diagnostics company developing a suite of genetic tests. Its product pipeline includes tests for genetic disorders, drug metabolism and infectious diseases.

Study cites causes of thrombosis

The results of a new study providing insight into the causes of thrombosis were presented last week at the 11th annual congress of the European Hematology Association (EHA) in Amsterdam, the Netherlands

The study was conducted by the University Medical Center Utrecht (UMCU) in the Netherlands, in conjunction with the University of Cambridge in the UK. It successfully identified the precise location where the von Willebrand-factor protein adheres to collagen – the first step in thrombus formation.

The researchers said this discovery makes it possible to begin developing medication to block platelet adhesion, marking a major step forward in the treatment of arterial thrombosis, or atherosclerosis.

Atherosclerosis begins with the inside vessel wall becoming “rough,” causing platelets to become stuck, which can, in turn, lead to the formation of blood clots. If thrombosis completely blocks the blood vessel, the downstream tissue no longer receives oxygen, causing an infarction to occur in the heart or in the brain.

The platelets stick to the damaged vessel walls via an “adhesive protein,” the von Willebrand-factor protein, named after its discoverer, Erik von Willebrand. The protein forms a bridge between the platelets and the collagen component of the vessel wall, which is exposed in damaged vessels.

Professor P.G. de Groot, researcher at UMCU, said, “'Further study may allow us to reduce adhesion of blood platelets to arteriosclerotic blood vessel walls. This could open doors to new treatments allowing us to influence the clinical consequence of arteriosclerosis.”

Also at the EHA meeting, two pioneering studies in the field of stem cell transplantation were presented. The first, conducted at the Leiden University Medical Center, demonstrated for the first time that environment-specific cells can play a role in positively influencing rejection reactions following stem cell transplants.

The second study, from the San Raffaele Scientific Institute (Milan, Italy), showed that a “suicide” gene can be used to cut short rejection reactions following stem cell transplants.

Both discoveries make stem cell transplants safer, and signify a step forward in the treatment of malignant blood conditions such as leukemia.