A Medical Device Daily

Medtronic (Minneapolis) reported receiving reimbursement approval in France for the Endeavor drug-eluting coronary stent (DES) system. The approval was published in the Journal Officiel de la Republique Francaise last week.

The company said the stent will be available June 21 to public and private hospitals throughout France, providing physicians and patients with another option for the treatment of coronary artery disease in one of the largest DES markets in Europe. About 165,000 stents are used in France each year, some 55% of them drug-coated stents.

Made of a cobalt alloy, the Endeavor stent has a unique modular architecture designed to enhance deliverability. In addition to the drug compound zotarolimus (ABT-578), Endeavor is coated with phosphorylcholine, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, leading to an ideal healing response, the company said.

Patrick Mackin, vice president of Medtronic's vascular business in Western Europe, said, “The Endeavor stent system provides an excellent combination of deliverability, effectiveness and safety, with long-term clinical results that clearly show it to be an ideal choice for physicians considering a drug-eluting stent for their patients.”

Medtronic presented data at last month's Paris Course on Revascularization that provided compelling clinical evidence demonstrating the long-term safety and efficacy of the Endeavor. Three-year and two-year results from the ENDEAVOR I and ENDEAVOR II clinical trials demonstrated low rates of repeat procedures, target lesion revascularization, as well as low rates of major adverse clinical events (MACE) such as death and myocardial infarction.

No late stent thrombosis was reported in either of the two trials. Late stent thrombosis is the formation of blood clots that potentially can lead to heart attacks or death. In all of its Endeavor clinical trials to date, there have been no reported cases of late stent thrombosis in more than 1,300 patients who have been followed for at least one year.

“The clinical data for the Endeavor stent is strong, with long-term safety and efficacy results that make it a welcome addition to the drug-eluting stent market in France,” said Jean Fajadet, MD, of Clinique Pasteur Unite de Cardiologie Interventionnelle (Toulouse, France) and a co-principal investigator of the ENDEAVOR II trial. “The safety record is very impressive, with no late stent thrombosis. Almost 90% of the patients who received an Endeavor stent are MACE free, and almost 94% required no further treatment or revascularization.”

The Endeavor stent has been commercially available in most of Europe and in many other international markets since August 2005.

UK minister urges improved efficiency

The UK's National Health Service (NHS) could improve patient care and save more than 700 million a year in the process by improving efficiency, according to Health Minister Andy Burnham.

Launching the NHS Institute for Innovation and Improvement, he published its first report detailing the savings that could be made by addressing areas such as:

  • Reducing avoidable emergency hospital admissions.
  • Increasing the number of operations carried out as day cases.
  • Cutting patients' length of hospital stays.
  • Slashing agency staff costs.
  • Reducing the number of wasted bed days.

The report contains recommendations for acute trusts and primary care trusts (PCTs) on how to improve patient care and increase efficiency.

Burnham said, “The NHS has come a long way in the last few years. The quality of patient care and NHS productivity is increasing, but we still need to do more to show value for money from the record investment that is going into the NHS.”

He said savings could come from a reduction in avoidable emergency admissions for conditions such as asthma, heart problems and angina; acute trusts achieving an average of 75% day cases across all specialties; and reducing unnecessary outpatient appointments by up to 50%.

“Increasing efficiency and productivity does not mean compromising services,” said Burnham. “The best trusts are already delivering on both – increasing efficiency and successfully managing their finances as well as providing high-quality patient care.

No Comments