A CDU

Boston Scientific (Natick, Massachusetts) last month reported receipt of the CE mark for the Taxus Libert paclitaxel-eluting stent system, its next-generation drug-eluting stent (DES) system. The company said the new platform has been designed to offer improved deliverability and conformability in challenging anatomy.

Taxus Libert is the first drug-eluting coronary stent system to incorporate a next-generation stent platform, Boston Sci said. It said the Libert stent features the Veriflex stent design, “an extremely flexible cell geometry with thin struts and uniform strut distribution.” The system also features the enhanced TrakTip catheter tip, mounted on the Maverick2 delivery catheter, to provide what Boston Scientific describes as “better lesion crossability.” The company said the TrakTip catheter tip has a low lesion-entry profile, which also is intended to improve crossability.

Boston Scientific said it plans to launch the product in European markets and other international markets where the CE mark serves as a regulatory qualifier. The Libert was launched earlier this year in certain international markets and is expected to launch in the U.S. in 2006.

Paul LaViolette, chief operating officer of Boston Sci, said, “The Taxus Libert stent system is designed to improve deliverability and conformability, providing physicians with state-of-the-art stent performance coupled with proven paclitaxel-eluting technology.”

“[This] stent system combines the new Libert stent platform with the rigor of the Taxus clinical program,” said John Ormiston, MD, interventional cardiologist at Mercy Hospital and the Green Lane Cardiovascular Unit of Auckland City Hospital (Auckland, New Zealand). “The Taxus Libert system offers enhanced ability to deliver across complex lesions, especially for patients with complex anatomies and tortuous lesions, and is designed to provide uniform drug delivery.”

Boston Sci received the CE mark for the bare-metal Libert stent system in December 2003 and FDA approval for the bare-metal version in January of this year. In May, the company reported 30-day safety data from its ATLAS pivotal study, designed to support FDA approval of the Taxus Libert system.

OrbusNeich Genous R stent gets CE mark

OrbusNeich (Hoevelaken, the Netherlands) said in late August that it had received CE-mark approval for its Genous Bio-engineered R stent. The company said Genous “is at the forefront of the accelerated natural healing approach to protect against thrombus and minimize restenosis. [It] promotes tissue healing to occur in a rapid and controlled manner at the stent injury, rather than inhibiting healing, including endothelial coverage, with antiproliferative drug-eluting stents.” The company said commercialization would be a controlled release in Europe and other international markets beginning in September through an Internet-based registry, e-HEALING.

Interim results from the most recent clinical study, HEALING II (for Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth), were presented at the EuroPCR meeting in Paris in May. That analysis showed that patients who received a Genous stent and also were on statins had better clinical outcomes. A HEALING III multifactorial clinical study will start in the next few months to assess the effect of statin therapy with Genous vs. bare-metal stents.

David Camp, vice president-sales and marketing. noted that “Genous is not a drug-eluting stent; there is no polymer or drug.” He said the stent is coated with an antibody that captures a patient’s own circulating endothelial progenitor cells. The concept, according to the company, is to cover the stent within minutes to hours with a layer of endothelial cells. “This not only minimizes restenosis but also provides immediate protection against thrombus,” Camp said.

Martin Leon, MD, associate director of the Center for Interventional Vascular Therapy in the division of cardiology at Columbia University Medical Center (New York), called the Genous technology “a promising development in the field of interventional cardiology, distinct from the basic concept of tissue inhibition of drug-eluting stents.” He described the technology as being “designed to act as a ‘magnet’ for endothelial progenitor cells to create a rapid and safe monolayer coverage for the implanted stent.”

Biosensors signs 3 firms to distribute DES

Biosensors International Group (Singapore) reported agreements with three additional medical device distributors in what it termed “key European cardiology markets.” It said the distribution agreements are expected to help it gain “significant” market share for the recently approved Axxion drug-eluting stent (DES) in Europe. The company said the agreements with Krauth Medical in Germany, Invatec in Italy and Palex Medica in Spain would serve to strengthen its access to key European markets, which now totals some 15 countries.

Jeffrey Jump, managing director of Biosensors Europe, said, “We ... have been able to attract top-tier distributors with proven track records of gaining significant stent market shares in Europe. [These] agreements have the potential to generate substantial sales of Axxion units in Germany, Italy and Spain.”

Axxion, which elutes the drug paclitaxel without using a polymer, became Biosensors’ first DES for the treatment of coronary artery disease to be launched within the European Union after it received the CE mark in mid-July. Over the first month since its launch, Biosensors already has made several shipments of the Axxion stent into the European market. The company said its DES revenues have increased “significantly” as a result.

“This favorable response over several weeks is very encouraging and is a testament of the market potential for Axxion,” said Yoh-Chie Lu, chairman and CEO of Biosensors. “We are confident that these new distributors, coupled with the existing network, will allow Biosensors to capture a meaningful market share in the next 12 months while waiting for our ... flagship DES, the BioMatrix.”

St. Jude, Cardiac Science in Japan approvals

St. Jude Medical (St. Paul, Minnesota) and Cardiac Science (Bothell, Washington) both reported receiving regulatory and reimbursement approvals from the Ministry of Health, Labor and Welfare in Japan for new products. St. Jude’s approval was for the Epic+ and Atlas+ implantable cardioverter defibrillator (ICD) product families, which the company said are the first of its ICDs available in Japan.

Engineered to anticipate a wide variety of diagnostic and therapy needs of ICD patients, the ICDs also are designed to make it easier for physicians to manage patients with atrial fibrillation (AF). Paul Bond, president of Getz Brothers Co. Ltd. (Tokyo), a St. Jude company, said, “Physicians will appreciate the ways they can improve patient care with this advanced technology, and ICD patients will appreciate the comfort made possible by the compact size of the devices.” In addition to Getz Brothers, the ICDs also will be distributed in Japan through Fukuda Denshi Co. Ltd.

“Japan represents the world’s second-largest medical technology market, with ICD implants growing at a rate of 20% to 30% annually over the past few years,” said Joseph McCullough, president of St. Jude Medical International. The Epic+ and Atlas+ ICD families include St. Jude’s AF Suppression algorithm, which provides technology to suppress episodes of atrial fibrillation, and AutoSensitivity Control, morphology discrimination and A-V rate branch, which are designed to help avoid unnecessary shocks and promote fast diagnosis and therapy with precise, patient-specific supraventricular tachycardia (SVT) discrimination. St. Jude said the Epic+ is the smallest ICD available in Japan capable of delivering a “clinically important” 30 joules of energy, while the Atlas is the most powerful device available in that country, providing up to 36 joules of delivered energy.

Cardiac Science received MHLW approval to market a biphasic version of the company’s automated external defibrillators (AEDs) in that country. The biphasic AED product, a private-labeled OEM version of Cardiac Science’s flagship Powerheart AED, will be marketed in Japan under the CardioLife brand name by Nihon Kohden (Tokyo), Japan’s largest medical device manufacturer.

Cardiac Science said its STAR (self-tracking active response) biphasic waveform customizes the defibrillation therapy for each patient by measuring each patient's ability to conduct electricity (impedance) and automatically customizing the waveform for that patient by varying duration, voltage and energy in order to optimize external defibrillation efficacy. Subsequent shocks progressively escalate to higher levels if additional shocks are needed to convert a sudden cardiac arrest victim to a normal rhythm.

Raymond Cohen, Cardiac Science chairman, said, “This biphasic submission has been under review by Japanese regulators for over two years, well beyond our initial expectation. As AED demand has grown in Japan, so has the demand for biphasic version AEDs. Nihon Kohden reports that substantial demand exists for our biphasic AED product.”

EC gives okay to J&J-Guidant deal

Johnson & Johnson (J&J; New Brunswick, New Jersey) said it has been notified that the European Commission (EC) has cleared its proposed acquisition of Guidant (Indianapolis).

That deal was valued at $25.4 billion when it was unveiled last December, but the troubles Guidant has had this year with recalls of several models of its implantable cardioverter defibrillators (ICDs) may impact the final valuation. As part of the clearance by the EC, Johnson & Johnson has agreed to divest its Cordis (Miami Lakes, Florida) steerable guidewires business and Guidant’s Endovascular Solutions (Menlo Park, California) business in Europe. J&J also said that “remedies addressing overlap in the endoscopic vessel harvesting product lines are also being pursued.”

USCI Japan to distribute AngioSculpt catheter

AngioScore (Alameda, California) and USCI Japan (Tokyo) entered into a distribution agreement for the AngioSculpt Balloon Catheter. The agreement provides USCI Japan with exclusive distribution rights in that country to distribute the AngioSculpt for all coronary applications. It also will be responsible for all registration activities for the product in Japan. In a separate transaction, USCI Japan made a $1.5 million equity investment in AngioScore.

AngioScore CEO Thomas Trotter said that USCI would provide AngioScore with “an outstanding lau-nch platform for the AngioSculpt once all the regulatory approvals have been obtained.”

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