A Medical Device Daily

AGA Medical (Golden Valley, Minnesota) reported that it has received approval from the Cantonal Ethical committee in Bern, Switzerland, to initiate enrollment in a new study examining the connections between migraine headaches and patent foramen ovale (PFO), a heart defect found in more than 20% of all adults. The company also recently reported FDA approval for a similar trial in the U.S. (Medical Device Daily, Feb. 10, 2006).

The PRIMA (Patent foramen ovale closure Reduction In Migraine with Aura) trial is a prospective, randomized, two-arm, multicenter trial to determine whether patients who undergo closure of a PFO with the company's Amplatzer device have a reduction in both the number and severity of migraine headaches. The study is expected to enroll about 120 patients at up to eight medical centers in Europe.

“The causes of migraine are still not clearly understood. If the results of the trial are positive, PFO closure may prove to be the first treatment that eliminates the cause of one form of migraine, instead of treating only the symptoms.“ said Dr. Heinrich Mattle, co-director of the Department of Neurology, University Hospital (Bern, Switzerland) and principal neurology investigator for the trial. “In addition to potentially resolving a major health concern in a specific group of patients, we may learn important factors in the origins of migraine that could advance treatment in other areas as well.“

AGA said that recent studies indicate that a significant number of patients experience a reduction in the frequency and severity of migraine headaches following closure of a PFO. The Amplatzer PFO Occluder offers a less-invasive alternative to open-heart surgery for closing a PFO.

The device is implanted via a catheter inserted in the patient's groin. The procedure typically takes from one hour to as little as 15 minutes among experienced physicians, and the patient is able to go home in less than 24 hours, according to the company.

Trial neurology and cardiology specialists will select migraine patients with aura, and provide randomized treatment of either PFO closure with the Amplatzer PFO Occluder, or medical treatment. The randomized trial is designed for comparative evaluation of the effectiveness of PFO closure in migraine reduction.

“Early on we recognized the importance of designing a device specific for PFO closure,“ said Franck Gougeon, president and CEO of AGA. “Introduced in Europe in 1998, our PFO devices have a well-documented record for successful closure combined with ease of use and a strong safety profile.“

TiGenix establishes New York office

TiGenix NV (Louvain, Belgium), a biomedical company focused on functional repair of damaged and diseased musculoskeletal tissues, reported that it has established TiGenix and opened its first U.S. office in New York City.

Most recently, TiGenix unveiled collaboration with the Hospital for Special Surgery (New York), which it said will assist in further developing ChondroCelect, its lead cartilage repair product. TiGenix said the new U.S. presence will support other medical institutions in the U.S.

“We are entering the U.S. market because we have a unique product in the orthopedic field that will enhance the quality of life for American patients,“ said Gil Beyen, CEO of TiGenix.

ChondroCelect is a cell-based therapy focusing on durable repair of cartilage defects of the knee. The product is used in combination with autologous chondrocyte implantation, a surgical procedure to treat cartilage defects by using the patient's own cells. By focusing on the regeneration of stable cartilage, ChondroCelect aims at creating durable repair of cartilage defects and postpones the progression toward osteoarthritis.

TiGenix said it is in the process of finishing its Phase III clinical trial in Europe for ChondroCelect and then will make preparations for FDA regulatory filings.

TiGenix was founded in 2000 as a spin-off of the universities of Leuven and Ghent. Its initial focus has been on the treatment of symptomatic cartilage defects in weight-bearing joints. Its proprietary adult stem cell technology prepares the route to an off-the-shelf product for cartilage repair and to the treatment of other musculoskeletal tissues.

The Hospital for Special Surgery is the oldest orthopedic hospital in the U.S. Its HSS Research Institute is considered a leader in the investigation of musculoskeletal and autoimmune diseases.

Tecserena new European distributor for Fonar

MRI pioneer Fonar (Melville, New York) reported the selection of Tecserena (Cologne, Germany) as its new European representative and distributor.

Tecserena is now marketing the Fonar Upright MRI and the Fonar 360, its work-in-progress operating room MRI, throughout Europe.

Tecserena was established as a distributor for Fonar's MRI products in Europe by Matthias Schulz, Alfred Schlemmer and Holger Frey. Prior to forming Tecserena, Schulz managed Hitachi Medical Systems Germany from 1999-2005. Schlemmer is the managing director of Tecserena and managed Hitachi's CT and MRI sales in Europe. Frey headed the marketing department for Hitachi Medical Systems in Europe and is the marketing manager for Tecserena.

“It is a coup for Fonar to have enlisted Tecserena as our representative in Europe,“ said Raymond Damadian, MD, founder and president of Fonar. “Tecserena's management team is extremely well versed in the field of MRI sales. The fact that they decided to leave Hitachi to focus exclusively on selling Fonar's . . . products. It supports what we have been saying all along: Humans walk erect. Evaluation of their problems mandate that when the source of the problems are being sought they must be evaluated in their position generating the problem.“

Fonar's newest MRI scanner is the Fonar 360, a room-size recumbent scanner that the company says “optimizes openness while facilitating physician access to the patient.“