Biosensors International (Singapore) said last month that its European subsidiary, Occam International (Eindhoven, the Netherlands), has received CE mark approval for the company's first drug-eluting stent (DES), Axxion, allowing its sale in the European Union. The Axxion DES is a polymer-free system that incorporates Biosensors' Calix stent delivery system and the drug paclitaxel, which is directly coated on the stent over a layer of glycocalix, a substrate designed to improve biocompatibility of the metal stent surface after the drug is released.
This technology is licensed exclusively by Occam from a privately held company in Germany that is a manufacturer of ultra-thin coatings that, according to Biosensors, "set unsurpassed standards of efficiency, hemocompatibility and biocompatibility."
Yoh-Chie Lu, chairman and CEO of Biosensors, said, "The 'polymer-free' approach potentially can reduce concerns about the long-term effects of polymer coatings used in competitors' products."
Chief Operating Officer Steve Thomson said, "In anticipation of CE mark approval, we have already ramped up our manufacturing and marketing preparedness. We are operationally ready to launch Axxion in selected markets, which is an essential part of our long-term strategy to have the commercialization of our own DES products drive the group's future revenues."
Biosensors said it expects European sales of Axxion to contribute to the company's revenues for the current financial year ending March 31, 2006, prior to receiving regulatory approval of its flagship DES system, BioMatrix, for which a CE mark filing was made in April. The BioMatrix DES system incorporates the company's proprietary anti-restenotic drug, Biolimus A9, bioresorbable polymer, S-Stent and stent delivery catheter, all of which have been developed in-house. Biosensors said it anticipates receiving CE mark approval for the BioMatrix in the first half of calendar 2006.
China okays Cardiac Science AEDs
Cardiac Science (Irvine, California) said it has received regulatory approval from China's State Food and Drug Administration (SFDA) to sell its latest line of automatic external defibrillators (AEDs), including its Powerheart brand public-access AEDs and the Powerheart CRM, a bedside monitor that automatically treats hospitalized cardiac patients who suffer life-threatening heart rhythms.
The approval provides clearance for Cardiac Science to begin shipments of its G3 series AEDs into China under the Powerheart and FirstSave brands, as well as under GE Healthcare's (Waukesha, Wisconsin) Responder brand name, which Cardiac Science manufactures on a private-label basis for GE. Cardiac Science-branded AEDs operate in the Chinese language and are sold through its local Chinese distribution partners. The GE Responder brand AEDs are marketed in China by GE Healthcare.
The AEDs are initially expected to be deployed primarily in medical and emergency rescue settings and used by hospitals, physicians and paramedics on fire vehicles and ambulances. More than 100 Powerheart CRMs are currently in use in Chinese hospitals.
Chairman and CEO Raymond Cohen said Cardiac Science has gained what he characterized as "a solid market share position" in emerging AED markets around the world, with international sales now accounting for about 40% of the company's revenue.
"People all over the world are recognizing that AEDs offer an effective and inexpensive way to protect citizens against sudden cardiac arrest," he said. "While the U.S. market continues to lead the way in the awareness and adoption of AEDs, we believe the international market now accounts for over 20% of worldwide AED sales."
UK okays clinical trial of BioSTAR
NMT Medical (Boston) has received approvals to initiate a multi-center clinical study in the UK to evaluate its new BioSTAR PFO (patent foramen ovale) closure technology. The BioSTAR Evaluation Study (BEST) will be the first in-human use of a bioresorbable collagen matrix incorporated on the company's STARFlex platform. Noting that the goal of the study is to secure European commercial approval for the BioSTAR technology through the CE mark process, NMT President and CEO John Ahern termed the approval of the BEST study "another important milestone for NMT and for our clinical researchers seeking better ways to treat their PFO patients."
Michael Mullen, MD, interventional cardiologist at Royal Brompton Hospital (London) and chief investigator for the BEST trial, said, "Based on preclinical research results, we believe that BioSTAR potentially offers a more natural, rapid and complete sealing of atrial level heart defects such as PFO."
He said that once delivered, BioSTAR creates a bioscaffold that promotes native tissue deposition. "During that process, the collagen matrix dissolves, leaving behind natural tissue that completely covers the STARFlex alloy framework."
The preclinical research was conducted in Germany by Christian Jux, MD, of the University of Goettingen, and Peter Wohlsein, DVM, of the Institute of Pathology in the School of Veterinary Medicine at Hannover. NMT said additional research support was provided by researchers at Johns Hopkins School of Medicine (Baltimore).
Ahern said that NMT has developed numerous research and technology collaborations over the past few years that "are now evolving into new, improved PFO closure therapies." He said that BioSTAR, "which combines an advanced biomaterial and our well-established STARFlex delivery platform, [is] one important outcome of that ongoing innovation process." He said the collagen matrix "has the potential to deliver and localize drugs, genes, cells and other materials that may further enhance PFO closure outcomes." The BioSTAR implant to be evaluated in the BEST clinical study, for example, will incorporate an ionically bound heparin substrate that elutes over time.
NMT Medical is investigating the potential connection between PFOs and brain attacks such as mig-raine headaches, stroke and transient ischemic attacks (see page 6).
CE mark for Arctic Front
CryoCath Technologies (Montreal), a developer cryotherapy products to treat cardiovascular disease, reported that it has received CE mark approval for three of its products: Arctic Front, a catheter designed for the treatment of atrial fibrillation (AF); a new generation console designed to work with the Arctic Front catheter; and the FlexCath deflectable sheath.
The company said that the CE-mark award was based primarily on "strong results" from a 20-patient study that saw more than 85% of the patients become AF-free after a six-month follow-up. The study was conducted at two European centers: Homalka Hospital (Prague, Czech Republic), under the direction of Dr. Vivek Reddy of Massachusetts General Hospital (Boston), and Dr. Petr Neuzil of the Czech Republic; and at the Kerkoff Klinik (Bad Nauheim, Germany), under the direction of Dr. H.F. Pitschner.
A second-generation catheter design, which incorporates advanced steerability and a larger balloon than the one used during the initial study, will be commercialized in Europe, CryoCath said.
Steve Arless, president and CEO of CryoCath, said, "We continue to believe that a minimally invasive solution to treat AF represents the most compelling opportunity in the field of cardiac ablation. A broader-scale launch of the Arctic Front System across Europe is anticipated later in the second half of this calendar year after an initial introduction in a number of thought leading centers."
During the initial rollout period, the company is aiming to treat and document more than 100 cases "to increase . . . clinical experience and understanding of Arctic Front and to establish an initial community of independent expert spokespersons to champion the new catheter system across Europe."