A Medical Device Daily

Evalve (Menlo Park, California), a developer of devices for the percutaneous repair of cardiac valves, said that the first series of patients have been successfully treated with its MitraClip system at St. Antonius Hospital (Utrecht, the Netherlands).

The company said the MitraClip system is the only medical device commercially available in the European Union which provides a non-surgical mitral valve repair option for patients suffering from the effects of mitral regurgitation (MR).

MR is the most common type of heart valve insufficiency in Europe and the U.S., affecting millions of people worldwide. In the vast majority of patients, the MR is untreated, requiring the heart to work harder and ultimately leading to heart failure.

The first patients in the Netherlands were treated by the team led by J. Van der Heyden, MD. "The MitraClip therapy provides a valuable alternative for those patients who are not good candidates for surgery," said Van der Heyden, of the hospital's department of interventional cardiology.

Evalve initiated commercial sales of the MitraClip system in Europe under the CE mark last September. The company is employing a direct sales strategy and the device is currently being implanted in four countries, including Germany, Italy, the UK and now the Netherlands.

Ferolyn Powell, president/CEO of Evalve, said, "Customer feedback about the MitraClip system has been exceptional. Physicians have experienced a quick procedural learning curve and have commented positively on the ease of use of the MitraClip system."

Powell added, "The most impressive physician responses have been based on the immediate observation of MR reduction and the resultant relief of symptoms in heart failure patients. Additionally, we hear positive comments on the physician's ability to place the MitraClip device on the beating heart without difficulty and how stable the patients are during the procedure. Evalve will continue to work diligently to make the technology available throughout the European Union."

Percutaneous mitral repair with the MitraClip is performed by physicians in the cath lab. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR.

Evalve is the first portfolio company from the medical device company incubator, The Foundry (also Menlo Park).

A first for MiCardia's Dynoplasty

MiCardia (Irvine, California) reported what it said was the world's first dynamic adjustment of the mitral valve annular geometry on a beating heart.

The procedure, performed by Professor Hans-Joachim Schafers, director of thoracic and cardiovascular surgery at Saarland University Hospital (Homberg, Germany) earlier this month, marked the first dynamic adjustment of MiCardia's new Dynaplasty mitral valve repair technology in the company's European Dynamic Annuloplasty Activation (DYANA) study, designed to provide data for CE-mark approval of the company's Dynaplasty Technology.

Schafers said, "MiCardia's Dynaplasty Technology was implanted in a standard surgical approach to correct an MVR of +3. Post-operative residual MR was corrected by remotely activating the device. This is the first time annular geometry has been adjusted to eliminate MVR in a beating heart. It represents a major step forward in technology".

Francis Shannon, MD, a cardiothoracic surgeon at Southeastern Michigan Cardiovascular Surgeons (Troy, Michigan) and a scientific advisor to MiCardia, noted, "The potential of Dynaplasty technology to non-invasively adjust the shape of devices implanted in the heart to improve the performance of the cardiac cycle is a major breakthrough in cardiovascular care. To my knowledge, MiCardia is the only company developing intra-operative, percutaneous and completely non-invasive dynamically adjustable devices for both mitral and tricuspid valve repair."

The company said it expects to complete enrollment and submit six-month follow-up data from the DYANA study later this year as a prelude to European commercialization of the world's first dynamically activated mitral valve repair system.

MiCardia received 510(k) clearance on the static version of its Dynaplasty System in the U.S. last September and implants will commence shortly at several centers. The Company said it plans to submit U.S. implant data as part of its European CE-mark submission and in turn capture critical clinical data from its European study to support regulatory submissions and commercialization of its systems in the U.S. subsequently.

The Dynaplasty technology is being developed for the treatment of structural heart disease, focusing initially on mitral and tricuspid valve disorders and as a method of interrupting a major element in the onset and progression of congestive heart failure.

Stronger international efforts for SBi

Small Bone Innovations (SBi; New York) reported taking several steps to expand and strengthen its international presence.

SBi recently acquired its German distributor and established Small Bone Innovations Deutschland (SBi Deutschland). It is based in Donaueschingen, which is located less than 80 miles from both Stuttgart, Germany, and Zurich, Switzerland.

Noting that it is in the process of relaunching the Scandinavian Total Ankle Replacement (S.T.A.R.) under the SBi brand, and has scheduled the first surgeries in Germany and Italy, the company said SBi Deutschland has acquired new customers for S.T.A.R. as well as other SBi products. It also has expanded its distribution network in Germany by contracting with an additional independent sales agent.

Anthony Viscogliosi, chairman/CEO of SBi, said, "With our business in France continuing to grow strongly and becoming further entrenched, we are now focusing our efforts to further raise our market presence in Germany."

He said the company has expanded its management team and strengthened its international organization by appointing Florian Kemmerich as president of Small Bone Innovations International, which is based in Bourg-en-Bresse, France.

Kemmerich, who is responsible for international sales and for developing new international markets, has extensive experience in the orthopedics markets in Europe, the U.S. and Latin America. Prior to joining SBi, he was managing director of B. Braun Melsungen and vice president, sales, Latin America for another B. Braun company, Aesculap.

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