A Medical Device Daily

NewCorTec (Pomezia, Italy) reported that a German patient is the first to log 365 days of support on the BestBeat ventricular-assist device (VAD), a new heart-assist device designed to provide cardiac support for patients with end-stage heart failure.

The patient was the first recipient enrolled in the international clinical study to prove safety and efficacy of the company’s VAD.

The implant took place on March 12 at the Herz-und Diabeteszentrum (Bad Oeynhausen, Germany), the heart surgery center of the University of Ruhr-Bochum.

The 68-year-old patient had been readmitted to HDZ Bad Oeynhausen earlier that month with severe ischemic cardiomyopathy. He was in need of transplant but, due to the worsening of lung function, NewCorTec said heart transplantation represented a substantial risk of unfavorable outcome. He was implanted with the BestBeat to keep him alive and allow him to regain good general health.

“[The patient] was on maximum medical support and facing imminent death, because of the progressive deterioration of his organ functions,” said A. El Banayosy, MD, director of the mechanical circulatory support department at the heart center. “The reason he is alive and doing well today is because the decision was made to implant the BestBeat VAD, which could guarantee an adequate perfusion of his body and promote his general improvement.”

The BestBeat is a pulsatile-flow VAD. The company said that because of its compact size, “it can be used for a wide range of patients in need of mechanical circulatory support.”

The device weighs about 450 grams and measures roughly 10 cm in diameter and 5 cm in width. NewCorTec said it is about half the size of similar, approved pulsatile devices such as the Novacor manufactured by World Heart (Oakland, California) or Heartmate One by Thoratec (Pleasanton, California).

Powered by a pushing plate mechanism, the BestBeat is categorized as a pulsatile-flow pump. It is designed to synchronize to the patient’s heart and to adapt automatically to metabolic needs. It is implanted in the abdomen and attached between the apex of the left ventricle and the aorta. An external system controller regulates pump operation.

The company said that, once implanted, the BestBeat “takes over most of the function of the left ventricle ... and helps generate the force necessary to propel oxygen-rich blood throughout the body. Without such circulatory support, patients are unable to produce blood flow adequate to meet their everyday life needs.”

NewCorTec initiated a multi-center safety and efficacy trial last year for the BestBeat to get CE-mark approval. The trial involves five centers in three European countries. Besides HDZ Bad Oeynhausen, the BestBeat has been implanted at Hopital La Pitié-Salpetriere (Paris), Policlinico San Matteo (Pavia, Italy), Niguarda Hospital (Milan, Italy) and CNR-CREAS Hospital (Massa, Italy).

“As of March 2008, we have implanted six patients in our trial, with very encouraging results,” said NewCorTech CEO Romano Ferrari. “Three patients continue to be supported by the device, spending most of their time at home. Median duration of support is around six months and, thus far, there have been no pump failures.”

He added, “The response from patients has been positive, and we have received interest from other centers regarding participation in the clinical study.”

The clinical study of the device is expected to be completed by this summer, and upon conclusion, the company aims at getting the CE mark before the end of 2008.

The LVAD is the result of a research project supported and funded over the last several years by the Italian Ministry of University and Research.

Medical Fair is new trade-name for expos

Messe Düsseldorf Group, a global provider of medical trade fairs, including the huge Medica exposition held in Düsseldorf, Germany, each November, said it will market its international medical care events under the brand name Medical Fair.

The company said the brand will follow the design of the Medica show, which it termed “the leading international trade fair.” It said that will establish “a visual link between the global No. 1 trade fair and its regional satellite events.”

Werner Dornscheidt, president/CEO of Messe Düsseldorf, said, “Since 1954 we have been organizing medical trade fairs, developing an outstanding reputation for ourselves around the globe and earning our customers’ confidence. With the new name Medical Fair, we are now creating a common framework for all our medical trade fairs held outside of Düsseldorf in order to raise recognition levels.”

The new strategy applies to all events held by the Messe Düsseldorf Group under its own name, as well as the medical fairs that until now were held under the name Hospimedica outside of Düsseldorf.

The first Medical Fair event was Medical Fair India, which concluded this past weekend in Mumbai.

Other scheduled events include Medical Fair Australia, set for May 13-15 in Sydney; Medical Fair Asia, in Singapore next Sept. 17-19; Medical Fair Brno, in Brno, Czech Republic, Oct. 21-24; and Medical Fair Thailand, set for Bangkok in September 2009.

Swedish hospital adds Sectra system

Södertälje Hospital said it is the first Swedish hospital to go live with Sectra’s (Stockholm, Sweden) new diagnostic workstation for radiologists, IDS7/dx. The workstation is part of Sectra’s PACS system for handling radiology images electronically and is optimized, the company said, for distributed reading of radiology images and handling extremely large datasets.

“With Sectra’s new workstation, our radiologists can review images at a location that best suits his or her individual situation, even from home. This enables us to use our resources in the most efficient manner,” said Peter Svozil, head of the radiology department at Södertälje Hospital. “Our cooperation with Sectra provides us the absolute leading edge of viable PACS technology based on real clinical needs that will make our everyday work easier.”

The IDS7/dx was launched in November at the annual meeting of the Radiological Society of North America. It is based on patent-pending technology for retrieving and displaying image data of extreme size. Sectra says the system “eliminates problems encountered in working with large datasets ... .”