A surgical team at the Centre Hospitalier Universitaire of Rouen (Rouen, France), led by Professor Alain Cribier, has placed an artificial aortic heart valve in a 57-year-old patient who was judged as inoperable using classical heart valve replacement techniques. This new procedure will provide hope to patients with faulty heart valves and who cannot withstand stresses of classical valve replacement surgery because of the seriousness of their health status.

Professor Cribier has been developing since the 1990s a new type of artificial heart valve that can be placed in position without surgery. After a number of successful animal procedures, this was the first on a human patient. The intervention, conducted under partial anesthesia, consists of insertion of a catheter by the classical femoral vein route. The catheter carries an artificial valve mounted on a metallic stent, which is placed immediately before the damaged heart valve. The objective was to reestablish blood flow to the heart and Cribier said that the result of the intervention, which took about two hours, was a "spectacular improvement" in the patient's health.

He said that the technique was particularly useful with high-risk patients or where surgery is contra-indicated. Cribier also suggested that the procedure, which is not difficult, could be particularly interesting in developing countries where there are few medical centers offering open-heart surgery.

Centerpulse to sell cardiovascular businesses

The former Sulzer Medica, now known as Centerpulse (Zurich, Switzerland), has decided to divest its cardiac and vascular businesses and concentrate efforts on its orthopedic, spine and dental implant and biologics business.

The businesses to be divested include the tissue and mechanical heart valve units, Sulzer Mitroflow and Sulzer Carbomedica (Angleton, Texas), the pacemaker business, Sulzer Intermedics (also Angleton), and the Vascutek unit (Abbotsinch, Scotland), which specializes in woven synthetic vascular protheses.

Analysts estimate that the sale of the Centerpulse cardiovascular businesses could raise up to $550 million, much of which is expected to be invested in the biologics division, located in Austin, Texas and which is researching the use of growth factor-related products, mostly for the orthopedic sector.

In other recent acquisition activity:

Jostra, a leading company in the field of medical technology for open-heart surgery (Hirrlingen, Germany), has completed its acquisition of the major fields of business of its main American competitor, LifeStream International (The Woodlands, Texas), for an undisclosed price. The operations that have been acquired will be continued by Jostra, and marketing will be integrated into the Jostra-Bentley unit (Irvine, California).

Abbott Laboratories (Abbott Park, Illinois) has paid $242 million to acquire the cardiovascular stent business of Biocompatibles International (Farnham, UK). The acquisition includes the worldwide marketing, manufacturing, development, distribution and licensing of intellectual property rights to the BiodivYsio coronary stent product line and the development pipeline of drug-eluting stents, together with the stent production plant in Galway, Ireland. The BiodivYsio coronary stent business acquired from Biocompatibles is being integrated into Abbott's vascular devices franchise.

Differentiating between stroke, heart attack

Proteome Sciences (Cobham, UK) has reported the development of a whole blood assay for stroke which, according to the company, could be the first test of its kind used in clinical applications. The blood markers identified using Proteome's protein separation technologies can diagnose stroke and also differentiate between stroke and heart attack

Proteome said that trials at the University Cantonal Hospital (Geneva, Switzerland) found the assay to be 100% specific and 68.2% sensitive, with a positive prediction accuracy of 100%. The company is in discussions with potential partners for licensing and commercialization of the assay.

Cholesterol-lowering drug looks good

AstraZeneca (London) has bucked the trend for bad news among pharmaceutical companies with the report that the FDA has indicated probable approval of its cholesterol-lowering drug, Crestor.

Crestor is the bright new hope for AstraZeneca, with a potential to generate peak annual sales of between $3 billion and $3.5 billion by 2008, according to some analysts. A successful launch now would help to offset the effect of generic rivals launching cheap versions of Losec, the ulcer drug which accounted for 40% of AstraZeneca's sales last year, but whose protective patents are now expired.

Although the company has declined to comment on remaining issues under discussion with the FDA, they are likely to relate to the drug dosage levels that would be approved. Regulators have become increasingly sensitive to the risks of cholesterol-lowering drugs since the withdrawal last year of Bayer's (Leverkusen, Germany) Baycol after more than 50 related deaths.

AstraZeneca has repeated earlier comments that if approved, it would not be able to launch Crestor before the fall. Jon Simonds, finance director, said in April that the drug would be ready for launch in the fourth quarter of this year, providing the approvable letter was received before the end of June.

Medicure starts trials on reperfusion drug

Medicure (Winnipeg, Manitoba) has begun enrollment for a multi-center Phase II trial to evaluate the cardioprotective effect of its lead drug candidate, MC-1, against potential damage caused by ischemia and ischemic reperfusion encountered by high-risk heart disease patients undergoing angioplasty. The placebo-controlled feasibility study will be run by the Duke Clinical Research Institute (Durham, North Carolina) and will enroll up to 100 high-risk patients scheduled for elective angioplasty surgery at European and North American sites. The company expects to report trial results by the end of this year.

Angioplasty preferable to medication

The Danish Danami-2 study has shown that many of the 4,000 Danes affected each year by a major coronary thrombosis will be helped more by balloon angioplasty than by traditional thrombolytic medication. The study has shown that angioplasty is preferable even where the patient has to be transferred over a fairly long distance to the nearest cardiac center. The study also concludes that there is a 75% lower risk of renewed coronary thrombosis after acute balloon dilation as compared to medical therapy.

Positive results for NO-donating aspirin

NicOx (Sophia Antipolis, France) has reported encouraging Phase I/IIa clinical trial results for their NCX 4016 nitric oxide (NO)-donating aspirin formulation, showing novel inhibition of vascular inflammation and platelet activity. As a result of these positive results, NicOx has initiated a Phase II trial to assess results in the treatment of symptomatic peripheral arterial disease.

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