A Medical Device Daily

Minnow Medical (San Diego), a developer of products to treat artery disease, reported receipt of the CE Mark, clearing its disposable catheter for marketing in the European Union.

The catheter utilizes the company's Guided Reshaping Technology (GRT) to treat peripheral artery disease (PAD). GRT treats artery disease by precise delivery of controlled radio frequency (RF) energy to open diseased arteries. The RF energy is delivered through electrodes on the surface of a disposable angioplasty balloon catheter.

"We are . . . pleased to receive the CE mark, and look forward to continuing to educate the European market about the advantages of our technology to treat PAD," said President/CEO Tom Steinke. "Our catheter system is easy to use, and involves a shorter, less-complex procedure compared with angioplasty, atherectomy or laser treatments."

He added, "We believe our technology represents a breakthrough that could dramatically reduce the use of stents in peripheral procedures."

Minnow is conducting clinical trials in Europe with a first-generation version of the catheter system.

Peripheral artery disease affects some 27 million people in North America and Europe, and many of the current treatments provide only limited or short-term benefit. Minnow said. The PAD device treatment market is estimated at $1.2 billion a year in the U.S. alone.

Minnow Medical is a developmental-stage company founded in 2003.

German physician reports on BSD treatment

BSD Medical (Salt Lake City) reported on clinical data presented by Rudiger Wessalowski, MD, associate professor at the Clinic of Pediatric Hematology and Oncology, Heinrich-Heine University (Dusseldorf, Germany), on the use of hyperthermia combined with chemotherapy and tumor resection to treat malignant germ cell tumors in children and adolescents.

Wessalowski presented an update of his clinical study at the annual Society for Thermal Medicine meeting earlier this month, reporting on the use of the BSD-2000 to treat 101 pediatric patients who ranged from age from 7 months to 17 years, with a median age of five.

Of these 101 patients, 46 patients had malignant germ cell tumors. Of the 46 patients with germ cell tumors, there were 23 patients who had a complete response (disappearance of all local disease) and eight patients with a partial response (greater than 50% reduction). The median follow-up was five years.

The best responders were patients who received the combined treatment as first-time therapy.

Wessalowski noted that standard therapies often are not effective for certain children's cancers, and relapse therapy is often not effective or available. The study was designed to not only improve survival but also avoid mutilating surgery.

UK distribution deal for Orthofix

Orthofix International (Boston) said it has signed an agreement with the MBA Group to expand the distribution of the company's spine implant and biologic devices in the UK.

MBA is the largest private independent distributor of orthopedic devices in Europe, generating more than $100 million in total sales in 2008. After having been Orthofix's exclusive distributor of orthopedic devices in Spain and Portugal for more than 20 years, MBA expanded its relationship with the company in 2008, becoming the U.S. firm's exclusive distributor of spine in those two countries.

The new five-year agreement covering the UK is effective May 1.

"MBA has been a key partner during Orthofix's growth over the last 20 years and, after successfully expanding our relationship last year to include the distribution of our spine implant products in Spain and Portugal, we are excited to further expand our spine distribution agreement with them into the important UK market," said Alan Milinazzo, president/CEO of Orthofix.

Paul Griffin, MBA chief operating officer, said, "MBA's excellent and longstanding relationship with Orthofix, together with our very successful 2008 spine launch, led to this latest agreement after the management teams from both organizations met to explore opportunities to further expand our mutually beneficial strategic partnership."

He added, "The UK is one of Europe's top five spine markets, and by combining Orthofix's . . . spine product portfolio with MBA's highly experienced UK management team and marketing know-how, we feel confident in our plans to develop a very successful business together in this key market."

Orthofix offers a broad line of minimally invasive surgical and non-surgical products for the spine, orthopedic, and sports medicine market sectors.

CIS distribution accord for Simbionix

Simbionix (Cleveland), a developer of medical simulation systems, reported an agreement with Johnson & Johnson LLC for distribution of Simbionix's simulators and related products.

The unit of Johnson & Johnson (New Brunswick, New Jersey) operates in Russia, Ukraine and Commonwealth of Independent States (CIS) countries. It will have exclusive rights to distribute Simbionix's line of advanced medical simulators in hospitals in Russia and the CIS countries.

"We are . . . excited to enter into this collaboration with Johnson & Johnson LLC to bring our advanced simulators into the Russian republic hospitals, teaching facilities and interventional clinics," said Simbionix CEO Gary Zamler. "This agreement ushers in a new era of simulation-based training for Russia's medical community."

"In the last year, Simbionix has increased its distribution channels and its exposure to the international market," said Doron Zilberman, VP of international sales. "We see Russia as one of the leading markets in the emerging medical world; this agreement is an additional step of our ongoing success in the international market."

Simbionix products provide medical experts with hands-on training in a comprehensive array of MIS procedures, including GI endoscopy, endourology, percutaneous access, advanced laparoscopic procedures and endovascular procedures.

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