A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported that it has received the CE mark for its Promus Element everolimus-eluting coronary stent system, the company's third-generation drug-eluting stent (DES) technology. The Promus Element system incorporates a unique platinum chromium alloy with an innovative stent design and an advanced catheter delivery system.

The company will begin marketing the Promus Element system immediately in the European Union and other CE mark countries. CE mark was granted by the Dutch Notified Body KEMA Quality B.V.

The platinum chromium alloy used in the stent is engineered specifically for coronary stenting. The company said this proprietary alloy offers greater radial strength and flexibility than older alloys such as the cobalt chromium alloy used in the Xience Prime DES, and it provides enhanced visibility and reduced recoil. The innovative stent design improves deliverability and allows for more consistent lesion coverage and drug distribution. The advanced catheter delivery system further improves deliverability.

"The platinum chromium alloy and new stent design used in the Promus Element stent represent significant innovations in drug-eluting stent technology," said Bruno Farah, MD, Clinique Pasteur (Toulouse, France). "In my experience, the Element platform offers a stenting option that provides superior deliverability and visibility with excellent comformability and low recoil. I believe it offers performance improvements that could simplify procedures and allow treatment of a broader range of patients."

In addition to the Promus Element system, the company said it plans to offer the Taxus Element paclitaxel-eluting coronary stent system. Both Element systems incorporate the platinum chromium alloy with the innovative stent design and advanced catheter delivery system.

"We are proud to introduce our third-generation drug-eluting stent to physicians and patients in Europe and other CE mark countries," said David McFaul, Boston Scientific senior VP, International. "We also plan to launch the TAXUS Element system in CE mark countries next year, giving physicians the choice of two proven drug and polymer combinations – used in millions of patients worldwide – on an entirely new stent platform. We are confident our Element series will further extend our global DES leadership."

The Promus Element system is being evaluated in the PLATINUM clinical trial, which completed enrollment of 1,532 patients in September at more than 140 sites worldwide. PLATINUM is a randomized, controlled, pivotal trial designed to support FDA and Japanese Ministry of Health, Labor and Welfare approval of the Promus Element system. The Taxus Element system is being evaluated in the PERSEUS trial, which completed enrollment in October 2008 and will report primary endpoint data at the American College of Cardiology (Washington) conference in March.

The company said it anticipates FDA approval for the stent system in 2012.

Marcol, Advent acquire Median Kliniken

Following competition approval from the European Commission, Terence Cole and Mark Steinberg's Marcol (London) has completed the acquisition of Median Kliniken (Berlin) with its partners Advent International (Boston) for an undisclosed sum.

Median is Germany's largest private rehabilitation care provider. It owns and operates 27 rehabilitation and acute clinics at 19 locations throughout Germany, with more than 6 million square feet of real estate, 6,300 beds, around 4,500 employees and an annual turnover of circa €300 million.

Completion of the acquisition follows many months of negotiations between Marcol and Median's founders "Median has one of the best management teams in the industry and is in a strong position to lead the consolidation drive, in a very fragmented sector, while maintaining and improving its primary position in the provision of services to the post acute rehabilitation sector. These include a wide range of areas, such as oncology, neurology, geriatrics, orthopedics, cardiology and psychotherapy," said Steinberg

The professional advisers appointed to assist in the acquisition include Rothschild, McKinsey, Lovells, CB Richard Ellis and Ernst & Young, who between them undertook extensive evaluation of the current business and future expansion potential.

"We aim to build Median into a €1 billion business within the next five years and substantial funds have been committed to support growth plans. Opportunities exist to grow organically as well as through expansion and further acquisitions," said Cole.

The growth plans will be developed and implemented by a management team led by new CEO Martin Siebert. A PhD graduate in both law and medicine, Siebert was previously Principal Director and Deputy Chairman of Asklepios Kliniken and he brings significant experience to Median.

Edwards, DexCom report CE mark

Edwards Lifesciences (Irvine, California) and DexCom (San Diego) reported the receipt of CE mark for an automatic glucose monitoring system. Edwards and DexCom co-developed this new system, which is indicated for automatic, real-time monitoring and trending of blood glucose concentration in critically ill adults in the hospital environment.

Market evaluations of a first generation product are expected to begin in a limited number of European sites before the end of the year.

Studies have shown that hospitalized patients can be at a higher risk of infection and other complications if their blood glucose level is elevated for prolonged periods. Currently, clinicians manage patients' glucose levels by manually obtaining intermittent samples over various periods of time. The companies believe that this new glucose monitoring system will perform multiple automatic readings per hour that may provide a new level of trending insight designed to enable clinicians to effectively implement glycemic control.