A Medical Device Daily

Cyberonics (Houston) reported receiving approval from regulatory agencies in Korea and Brazil to market its VNS [vagus nerve stimulation] Therapy Models 102 and 102R generators and VNS Therapy Model 302 leads in those countries for the treatment of pharmacoresistant epilepsy.

Those approvals "provide improved commercial access to our VNS Therapy Systems for the safe and effective treatment of medically refractory epilepsy in Korea and Brazil," said Michael Cheney, vice president, marketing.

He added: "Part of Cyberonics' plan to become the global neuromodulation market leader following final depression approval is to increase our investments and penetration of international markets."

Cheney said the company already has received sales orders for the newly approved products and plan immediate shipment into the two new markets.

"We are pleased to have the opportunity to improve the lives of people in Korea and Brazil suffering from pharmacoresistant epilepsy," he said, adding that Cyberonics "look[s] forward to continuing the expansion of our global VNS Therapy franchise."

The company said the Model 102 and Model 102R generators are slimmer, lighter and easier to implant than their predecessor, the Model 101 Generator. The Model 102R Generator is a dual-connector version of the Model 102 Generator for use as a replacement for Model 100 and 101 generators with dual-connector Model 300 leads that have reached end of service.

Cyberonics, which was founded in 1987, is focused on developing devices for the long-term treatment of epilepsy, depression and other chronic neurological disorders vagus nerve stimulation therapy.

Stimulation is delivered by an implantable generator similar to a cardiac pacemaker. The VNS Therapy System delivers preprogrammed intermittent mild electrical pulses to the vagus nerve – which is located in the patient's neck – 24 hours a day.

The company's initial market is epilepsy, the second-most-prevalent neurological disorder. The VNS Therapy System was approved by the FDA in 1997 for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to anti-epileptic medications. The system also is approved for sale as a treatment for epilepsy in all the member countries of the European Economic Area, Canada, Australia and other markets.

Cyberonics said that to date, more than 30,000 epilepsy patients in 24 countries have accumulated more than 79,000 patient years of experience using VNS Therapy.

The VNS Therapy System was deemed "approvable" by the FDA in early February as an adjunctive treatment for chronic treatment-resistant depression for adults over the age of 18. Final approval is conditional on final labeling, final protocols for a post-approval dosing optimization study and patient registry, satisfactory compliance with Quality System Regulations and satisfactory resolution of any outstanding bioresearch monitoring issues.

The VNS system already is approved for sale in the European Economic Area and in Canada as a treatment for depression in patients with treatment-resistant or treatment-intolerant major depressive episodes, including unipolar depression and bipolar disorder, or manic depression.

Cyberonics also has VNS Therapy at various levels of investigational study as a potential treatment for anxiety disorders, Alzheimer's disease, chronic headache/migraine and bulimia.

Mesomark test gets launch in Australia

Fujirebio Diagnostics (FDI; Malvern, Pennsylvania) said it has signed a distributor agreement with Australian-based Vital Diagnostics for its new Mesomark blood test for mesothelioma. The agreement marks the beginning of the company's commercial roll-out of Mesomark, now available for the first time in Australia.

"The launch of Mesomark . . . greatly enhances our product portfolio, underscoring our commitment to commercialize high quality diagnostic tools that improve cancer patient care," said Dr. Jeffrey Allard, vice-president and chief scientific officer at FDI. "[It] is the first in vitro diagnostic test for patients with mesothelioma and has the potential to improve survival rates and quality of life for patients with this aggressive and often fatal disease."

Mesothelioma is a rare form of cancer in which fluid accumulates between the lining of the lungs and chest cavity. It is primarily caused by work-related asbestos exposure and has a latency period of up to 75 years. It is estimated that 10,000 new cases are diagnosed each year among industrialized countries.

Mesomark is a manual enzyme-linked immunosorbent assay (ELISA) for managing mesothelioma. It works by identifying a group of molecular markers called soluble mesothelin-related proteins (SMRP), which are released into the bloodstream by mesothelioma cells.

Fujirebio said that because SMRPs can be elevated for several years before an actual diagnosis of mesothelioma can be made, the Mesomark test will help in the routine monitoring of asbestos-exposed individuals who are at greatest risk for developing mesothelioma.

Vital Diagnostics, formed as Clinical Data in February 1993, is a leading independent niche marketer of laboratory diagnostics and instrumentation to the Australasian diagnostics market. It promotes its products in the Australasian market via key account managers based in Auckland, Sydney and Melbourne, Australia, and Auckland, New Zealand.

Pronto catheter approved in Japan

Vascular Solutions (Minneapolis) said that it has received notification from the Japanese Ministry of Health, Labor and Welfare of regulatory approval for its Pronto extraction catheter.

The company said it expects to complete the import license and reimbursement notification for sales of the Pronto catheter to begin in Japan in 3Q05.

The Pronto catheter is designed for the mechanical aspiration removal of acute thrombus from the arterial system.

Japanese subsidiary for Ambion

Ambion (Austin, Texas) reported the formal opening of its Japanese subsidiary, Ambion KK, located in Tokyo. Ambion KK is the latest expansion of Ambion, a 15-year-old company that manufactures research and diagnostic products for RNA-related applications to academic, industrial, clinical and government biotechnology scientists.

Dr. Yosuke Sawada has been appointed president of Ambion KK. The Japan office has been established to focus on providing quality technical and customer service and fast direct shipment to dealers and customers.

Dr. Matt Winkler, CEO, said, "This is a natural evolution in our growth. Our ability to offer services directly to our customers in Japan will allow us to develop closer relationships and offer additional services that will enhance their experience using our products and working with Ambion."