A Medical Device Daily
Terumo Europe Interventional Systems (Leuven, Belgium), an affiliate of Terumo (Tokyo), reported at last week’s EuroPCR 2005 meeting the enrollment of the first patient in the NOBORI 1 drug-eluting stent (DES) clinical trial.
NOBORI 1 is a prospective, randomized clinical trial that will enroll 360 patients in 30 centers in Europe, Australia and Asia. The equivalency study will compare Terumo’s Nobori Biolimus A9 drug-eluting coronary stent to Boston Scientific’s (Natick, Massachusetts) sector-leading Taxus Express2 DES.
Georgios Sianos, MD, of Erasmus University Hospital (Rotterdam, the Netherlands), enrolled the first pati-ent in the trial during a live case transmission at the EuroPCR conference at the Palais de Congr s in Paris. “I am very pleased to implant the first Nobori stent which showed excellent performance in this difficult case and I am looking forward to [seeing] the results of this study.”
The primary endpoint of the trial is nine-month in-stent late loss. Secondary endpoints include angiographic binary restenosis, target lesion revascularization (TLR), target vessel revascularization (TVR) and target vessel failure (TVF) rates at nine months; major adverse cardiac events (MACE) at 30 days, four, nine and 12 months and annually up to five years; in-stent thrombosis at 30 days and nine months; and lesion, device and procedure success.
The principal investigator of the study, the first head-to-head comparison DES trial involving a bioabsorbable polymer, is Bernard Chevalier, MD of Centre Cardiologique Nord (Saint-Denis, France).
Yuutaru Shintaku, president of Terumo Interven-tional Systems, said the initiation of the NOBORI 1 clinical trial “represents a significant milestone for our company,” adding that the Nobori DES offers cardiologists a “valuable alternative for the treatment of patients with coronary artery disease.”
The Nobori stent elutes Biolimus A9, an immunosuppressive drug developed for stent applications by Bio-sensors International (Singapore/Newport Beach, California), a company with which Terumo signed an alliance agreement for the co-development and distribution of drug-eluting stents (Medical Device Daily, Oct. 29, 2003). Biolimus A9 has been shown in preclinical and clinical testing to inhibit smooth muscle cells proliferation and restenosis.
The stent platform is S-Stent, a corrugated ring stent, which Terumo said combines repeating S symmetry and very short segment lengths to provide “excellent flexibility and high vessel wall support in both straight and curved vessels.” The company said the flexibility of S-stent “allows it to be placed even into tortuous vessels, and enhances conformability with the blood vessel after implantation.”
Terumo said the S-Stent design “features a uniform and repeating pattern in order to achieve the objective of uniform drug distribution in the vessel wall as the drug is released from the stent struts.”
The drug carrier is poly-lactic acid (PLA), a biodegradable polymer that degrades primarily by hydrolysis; the degradation product is water-soluble lactic acid. It gets absorbed by tissue and is eventually converted to water and carbon dioxide.
The company said the drug/polymer matrix is coated exclusively on the outer, abluminal surface of the stent, which helps decrease systemic exposure of the patients to the drug and targets vessel wall tissue.
Terumo manufactures a range of medical products, including cardiovascular systems, disposable medical devices, therapeutic catheters, IV solutions, blood bags, diabetes care systems and medical electronic products, selling them in more than 150 countries.
artus Gesellschaft to be acquired
Qiagen (Venlo, the Netherlands), which describes itself as the leading global provider of enabling technologies and products for the separation, purification and handling of nucleic acids and proteins, said that its Qiagen GmbH subsidiary has entered into a definitive agreement to acquire artus Gesellschaft (Hamburg, Germany).
artus GmbH specializes in the production of diagnostic kits based on DNA analytical procedures. The main focus of these detection procedures is polymerase chain reaction (PCR) and real-time PCR technology, and the systems are mainly used in identifying infectious agents, in pharmacogenomics and in veterinary diagnostics.
The company was established by six scientists as a spin-off of the Bernhard-Nocht-Institute for Tropical Medicine in Hamburg in 1998 with the intention to develop new procedures and products for pathogen diagnostics.
In November 2000, artus was the first laboratory that tested a cattle positive for bovine spongiforme encephal-opathy (or “mad cow” disease) in Germany.
artus also was the first company to sell a commercial amplification and detection system for the severe acute respiratory syndrome (SARS) coronavirus during the SARS epidemic, doing so in April 2003.
Dermal filler launched by Mentor
Mentor (Santa Barbara, California) has launched its Puragen dermal filler product in Europe. Puragen is the new brand name for Mentor’s next-generation, non-animal-based, hyaluronic acid dermal filler, which is manufactured with the company’s double cross-linked (DXL) technology.
Nicholas Lowe, MD, a dermatologist and cosmetic surgeon with practices in London and Santa Monica, California, said Puragen represents “an important advancement for patients and gives a very smooth injection, resulting in a uniform filling to the lips and lower face lines.”
Lowe said his European patients “are pleased with the results of the product thus far, which appears to provide a long duration of wrinkle correction.”
Mentor said Puragen is a pure form of hyaluronic acid derived from bacterial fermentation and does not have the risks associated with products derived from animal byproducts. It said the product “is uniquely stabilized through [our] DXL technology, which introduces two discrete double cross-linking reactions to provide improved product stability relative to all other commercially available hyaluronic acid-based dermal fillers on the market in Europe, Canada and the U.S.”
Mentor is currently conducting a pivotal clinical study of Puragen in the U.S. that is expected to be completed before year-end 2005.