CDU

Biocompatibles (Farnham, England) has set up a new drug delivery research and development group that will use virtually all of the company's R&D resources to develop stents preloaded with drugs and other biomaterials to combat restenosis. "Five percent restenosis with zero late thrombosis" is the development target, a company spokesman said.

In collaboration with Abbott Laboratories (Abbott Park, Illinois), Biocompatibles' cardiovascular strategic partner and eventual U.S. marketer, three R&D programs have been set up. The first will continue existing research with already discovered drugs and initial clinical trials later this year. The second project will develop new drugs for pre-loading on stents, while the third will involve biomaterials – including gene therapy, growth factors and tissue-engineered products.

Several drug development companies already are working on candidate drugs for inclusion in Biocompatibles' phosphorylcholine (PC) stent coating.

There is a risk of late-stage thrombosis following stenting and subsequent aggressive anti-restenosis therapy. Acknowledging this problem, the company said, "It is important that the risk of thrombosis is not increased by any new anti-restenosis therapies. We have therefore established a goal of 5% restenosis with zero late thrombosis. If and when we can demonstrate that, then a zero restenosis goal would be appropriate."

Angioplasty better as second-line treatment

Although angioplasty is more effective than medical treatment in cases of severe angina, its use may not be appropriate in patients with mild angina. Professor Thomas Lusher, of the Zurich University Hospital (Zurich, Switzerland), said, "We shall not harm patients by using drug treatments first and using angioplasty only if symptoms persist."

A team of Canadian and Swiss researchers carried out a meta-analysis of six randomized, controlled trials involving nearly 2,000 patients with non-acute coronary heart disease. According to Heiner Bucher and colleagues at the Kantonsspital (Basel, Switzerland), percutaneous transluminal coronary angioplasty (PTCA) should be reserved for patients with angina that cannot be controlled by drugs alone.

Bucher said that the overall picture arising from their analysis was that angioplasty produced better control of angina than treatment with antiplatelet agents, beta-blockers, nitrates or calcium antagonists. Nevertheless, patients treated with PTCA were more likely to need coronary artery bypass grafting (CABG) during later stages of the disease.

An estimated 2.5 million PTCA procedures took place worldwide in 1999, with 55% in North America, with the market sector valued at $700 million, growing about 11% annually.

Aggressive approach best in unstable angina

After a one-year follow-up of almost 2,500 patients with unstable coronary artery disease in Sweden, the authors of the FRISC II (Fast Revascularization during Instability in Coronary artery disease) study report that invasive treatment (PTCA or CABG) was associated with better outcomes, but at a cost of 15 more bypass procedures and 21 more angioplasties per 100 patients.

The follow-up results showed that an invasive strategy saved 1.7 lives, prevented two non-fatal infarctions and 20 hospital re-admissions for every 100 patients treated. Additionally, invasive treatment involving angioplasty provided better and earlier symptom relief.

Patients receiving the noninvasive treatment received twice daily subcutaneous injections of dalteparin (Fragmin) from Pharmacia (Uppsala, Sweden). All patients also received aspirin with beta-blockers, nitrates and calcium antagonists administered as appropriate.

French aortic stent safety review

The French health care product safety agency, AFSSAPS (Paris), plans to publish later this year the results of an investigation into the safety in use of abdominal aneurysm stents following a series of incident and near-incident reports.

Although there apparently have been no major problems resulting from product design or fabrication, the investigation is expected to show that most problems are associated with user error. It may be necessary for manufacturers to improve information materials supplied with the stents, said Jacques Dumont, president of the French medical device industry association, SNITEM.

European product launches

  • The GDC Tri-Span Coil from Boston Scientific (Natick, Massachusetts) has received CE marking and has been launched on the European market. It allows complex brain aneurysms to be treated less invasively by acting as a scaffold at the aneurysm opening to contain other subsequently placed GDC coils.
  • Guidant's (Indianapolis, Indiana) latest Multi-Link Tetra stent has been launched in the European market after completion of CE marking formalities. The device is awaiting FDA approval before starting marketing in the U.S. Separately, Guidant has started a U.S. clinical trial to assess the new Multi-Link Pixel coronary stent for treating de novo or recurrent blockages in smaller vessels with diameters of less than three millimeters.
  • Intraluminal Therapeutics (St Paul, Minnesota) has raised $15.5 million to finance the launch in Europe of Safe-Steer TO, its first-generation total occlusion crossing catheter system. The funds also will be applied to development of a second-generation catheter and completion of clinical trials for a 510(k) approval application to the FDA. Safe-Steer TO is the first device in a family of products using forward-looking guidance and control technology to cross and recanalize safely totally occluded vessels. The company uses optical coherent reflectometry, a system which produces an image resolution 10 times better than ultrasound, an IntraLuminal spokesman said. Safe-Steer TO is in clinical trials at three European cardiology centers and preliminary reports have shown success rates of 42% to 72%, depending on the age and nature of the plaque.

Acorn Cardiac Support Device launch eyed

Initial Phase I safety trials of the Cardiac Support Device (CSD) from Acorn Cardiovascular (St. Paul, Minnesota) were successful, and a worldwide randomized clinical efficacy trial is now under way, according to Jan Fowler, Acorn's director of marketing services.

The company plans to complete CE marking later this year, with a European market launch soon after.

Fowler said that Acorn could be in a position to submit an application for marketing approval of the CSD to the FDA next year. The CSD is a polyester mesh that is stitched into place around the heart to provide ventricular support and to prevent the heart muscle from further dilation. The product is targeted at heart failure patients at an early disease stage and prior to a need for a heart transplant.

Aventis withdraws anticoagulant application

Aventis Pharma (Frankfurt, Germany) has withdrawn its EU marketing application with the EMEA agency in London for regulatory approval of the anticoagulant Refludan (lepirndin) in the treatment of acute coronary syndromes. The application was filed in July 1999. The decision to withdraw the application follows a recent non-approvable letter from the FDA regarding an equivalent U.S. submission for the drug.