A Medical Device Daily

The Sorin Group (Milan, Italy), Europe’s largest cardiovascular medical device company, and Japan Lifeline (JLL; Tokyo), a distributor of medical devices, have signed a 10-year partnership agreement whereby JLL will distribute Sorin’s cardiac rhythm management (CRM) devices throughout Japan.

Sorin said it expects that the agreement will “significantly” boost its market share in that country.

More than 200 field representatives, coming both from JLL and Sorin’s Japanese subsidiary, will distribute Sorin’s CRM devices. The united sales force, which will be employed by JLL, “will secure greater penetration in this growing, sophisticated medical technologies market,” Sorin said. In 2006, Japan had more than 50,000 pacemaker and in excess of 3,500 defibrillator implants, for a total value in excess of 1360 million.

JLL already distributes the Sorin Group’s Carbomedics-brand heart valves in Japan. The new partnership agreement takes effect Sept. 1.

Sorin noted that the partnership comes at a time when the company has just received approval for its family of Ovatio ICD devices in Japan. It said the Ovatio is “the world’s smallest implantable defibrillator and has already had great success in Europe and the U.S.”

“JLL is the perfect partner to help us in growing market share in Japan,” said Andr-Michel Ballester, president of Sorin’s cardiac rhythm management business unit. “Our innovative product line and JLL’s wide-reaching distribution network are the perfect combination for success in this market.”

“With over 25 years of experience, JLL has provided the newest and best medical devices to our client base,” said Keisuke Suzuki, CEO of Japan Lifeline. “With the addition of Sorin Group’s CRM products and technology, JLL is confident we will continue to provide increased value to the patients and medical facilities we serve. We believe that our professional sales force and expanded product line will enhance the presence of both companies in the Japanese market.”

CSMG advances product in Russia, Ukraine

CSMG Technologies (Corpus Christi, Texas), a technology management company, said the Russian Federal Service of Health Care and Social Development has approved the tissue-welding electrosurgery generator and eight instruments for commercial use in its hospitals and clinics. The approval is for a wide range of procedures that the universal electrosurgical generator and its instruments perform.

The approval was issued to CSMG’s Ukraine partner, International Association Welding (IAW).

“This is an achievement of monumental proportions for IAW and CSMG,” said Donald Robbins, president and CEO. “We expect to immediately begin implementing our plans with IAW to manufacture, market and distribute the tissue-welding electrosurgery device and hand instruments in both Ukraine and Russia.”

Robbins said a team of surgeons, scientists, patent authors and engineers are working on the technology at the E.O. Paton Institute of Electric Welding (Kiev, Ukraine). “The Ukraine team, along with our medical device design, manufacturing, marketing and management team in the U.S. and the immediate filing with the FDA brings this unique medical device technology to the forefront of the surgery industry,” he said. “We believe sales in Russia and Ukraine could reach $7 million to $10 million in 2008 and could grow at a rate of as much as 50% per year for the next several years in these two rapidly expanding medical markets.”

Robbins said Russian clinical work was performed by surgeons at Hospital #1 (Moscow) and Povlov University Hospital (St. Petersburg).

Aethlon to begin study in India

Aethlon Medical (San Diego) said it has received approval to initiate clinical testing of the Hemopurifier in human studies to be conducted at Fortis Hospital (Delhi, India). The study will evaluate safety of the HemopurifierAE in up to 10 patients with end-stage renal disease.

Pending patient accrual, the study is expected to begin in August. Dr. Vijay Kher, director of nephrology at Fortis, will be the principal investigator. Kher previously acted as principal investigator of a Hemopurifier study conducted at the Apollo Hospital in Delhi that documented initial safety of the HemopurifierAE, and provided early efficacy observations during 24 treatments administered to health-compromised dialysis patients co-infected with hepatitis-C (HCV).

Aethlon said the Fortis study supports its strategy to pursue early treatment and commercialization opportunities in India. The company said it will focus on viral conditions of greatest concern to Indian citizens, and opportunities that offer treatment access to the Hemopurifie within India’s growing medical tourism industry. Targeted conditions may include dengue hemorrhagic fever, HIV/AIDS and HCV.

Introduction of the Hemopurifie into the marketplace will be based on obtaining sufficient clinical data to drive practitioner acceptance in the marketplace. As with previous pre-clinical and clinical programs in India, Aethlon said it will seek additional support and guidance from the Indian Council of Medical Research .

Advanced Bionics in Hong Kong accord

Cochlear implant manufacturer Advanced Bionics (Valencia, California) and the Hong Kong Hospital Authority , a public hospital management association, reported entering into an alliance to bring the gift of hearing to the severely-to-profoundly deaf of Hong Kong.

The tender, effective July 1, continues a partnership that began in 2005, and authorizes Hong Kong’s exclusive use of Advanced Bionics’ new Harmony HiResolution Bionic Ear System.

Advanced Bionics recently introduced the Harmony HiResolution Bionic Ear System. The two key components of the Harmony System are designed to provide a more natural representation of sound.

The Hong Kong Hospital Authority manages Hong Kong’s 38 public hospitals and institutions. Advanced Bionics is the neuromodulation division of Boston Scientific (Natick, Massachusetts).