A Medical Device Daily

Allium Group (Caesarea, Israel), a maker of stents for the urinary, gastro-intestinal, pulmonary and peripheral vascular tracts, reported being warded the CE mark for its large-caliber, removable posterior urethral stent.

The Allium Bladder-neck Stent is a removable device comprised of a super-elastic structure inserted into the posterior urethra of patients who have undergone radical prostatectomy (for prostate cancer) and radical cystoprostatectomy (for bladder cancer). In up to 18% of these patients, a stenosis may develop at the anastomosis site, necessitating repeated dilatations to allow for a reasonable voiding.

The company noted that the conventional management of such stenoses is frequent mechanical dilations, endoscopic incisions or laser vaporization. It said the success rate of these procedures is low and patients have to undergo repeated treatments.

The bladder-neck stent was developed based on the experience of Professor Daniel Yachia, who successfully used removable stents in this difficult-to-treat area.

Yachia, a urologist who is the founder and chief scientific officer of Allium, said, "With the CE Mark, more European hospitals and physicians can offer their patients with Allium's new stents as a viable option that does not require a highly specialized reconstructive bladder neck repair procedure."

He added, "More urologists will ... be able to perform this simple, once-a-year treatment under regional anesthesia proven to be more effective than conventional treatments which have to be repeated frequently."

CEO Limor Domnitz Gishri said, "Allium's technology is rapidly gaining an established presence throughout Europe as more hospitals and physicians discover the significant advantages of using removable stents as an effective solution."

He added that the company "is at the forefront of the expanding stent industry, developing the only next generation stents designed to fit site specific areas in the urinary and gastro-intestinal tracts. [Our] goal is to provide the global medical market with the tools to enhance patient treatment, comfort and quality of life with a minimally invasive approach."

Allium's biliary and ureteral stents are currently being distributed through numerous partners in various European markets, including Italy, the UK, Germany and Austria,

the Benelux countries, Spain, Greece, Scandinavia and South Africa.

Peripatch Aegis receives CE mark

Neovasc (Vancouver, British Columbia), a new specialty vascular device company, said it has received CE-mark approval for Peripatch Aegis, its biocompatible product designed to reduce complications from endoscopic surgery. Peripatch Aegis is a buttressing material designed to reinforce the staple line and prevent bleeding and leaks during bariatric and thoracic endoscopic surgical procedures.

The approval enables the company to begin marketing Aegis products for sale in the European Union. The Peripatch Aegis products will be marketed in Europe through Neovasc's network of independent distributors.

"Leakage in endoscopic procedures can result in serious complications for patients, so we specifically designed Peripatch Aegis to enable endoscopic surgeons to reinforce surgical staple lines efficiently and effectively," said CEO Alexei Marko.

Neovasc, formerly Medical Ventures Corp., is a new specialty vascular device company comprised of the former Medical Ventures, Neovasc Medical Ltd. and B-Balloon Ltd.

It develops devices for the vascular and surgical marketplace, with a current line of products including Metricath for intravascular measurement and Peripatch surgical tissue and staple line reinforcement products.

Dialysis firm expands in Europe

Diaverum(Lund, Sweden), formerly Gambro Healthcare, reported that it has acquired two dialysis clinics in Germany and five in Turkey, thereby increasing the number of patients served by 700. The company said the acquisitions are in line with its strategy to expand its operations in a number of selected markets with good growth potential.

In addition, Diaverum has established a joint venture in Romania, together with a well-known local partner, Renamed Farma. The purpose is to obtain a market leader position in that country during 2009 by means of acquisitions.

Diaverum has 15 years of experience in dialysis treatment and is one of the world's leading providers of kidney health care. It is the second-largest dialysis provider in Europe. The company runs 178 clinics in 15 countries and its goal is to double the number of patients under treatment by 2011, from 13,000 in 2007 to 26,000 by 2011, and revenues from 3 billion SEK to 6 billion SEK.

CEO Dag Andersson said, "We are very satisfied having been able to acquire these new clinics in our high-priority growth markets Germany, and Turkey, and with our entry into the Romanian market. Our intention is to further increase our activities in these markets during 2009. At the same time our ambition is to further establish operations in a number of markets where we are still not present."

In order to facilitate further expansion in the growth markets of Germany and Eastern Europe, Diaverum has opened an office in Munich, Germany, which serves as the base for a large part of the company's management, including Andersson.