Boston Scientific Wins Device Approvals Worldwide

Boston Scientific Corporation enjoyed several device approvals and clearances this week.

The Natick. Mass.-based medical device company received CE mark approval for its Vercise deep brain stimulation (DBS) system to treat intractable primary and secondary dystonia, a neurological movement disorder characterized by involuntary muscle contractions.

Dystonia affects more than 500,000 people across Europe, including children and adults. It is the third most common movement disorder after Parkinson’s disease and essential tremor. Symptoms include involuntary muscle contractions, with twisting, repetitive movements or abnormal postures, which can be painful and debilitating. According to the company, the Vercise DBS system is the first designed to selectively stimulate targeted areas of the brain in order to customize therapy and manage symptoms of Parkinson’s disease. This system now offers new hope for patients with dystonia.

The first implant of the Vercise DBS system was performed by a team from the Charité Campus Virchow-Klinikum, which included Andrea Kühn, M.D., department of neurology, and Gerd-Helge Schneider, M.D., department of functional neurosurgery.

“Historically, treatment of secondary dystonia has been challenging and efficacy was typically incomplete and partially limited by side effects,” said Kühn. “The Vercise DBS system represents an advancement in dystonia care by providing more flexible and unique programming options for targeted deep brain stimulation tailored to each individual.”

“The device itself is designed to offer additional patient benefits including the longest battery life available for DBS and the smallest implanted stimulator footprint, especially important for our young patients,” said Schneider.

“The Vercise DBS system’s advanced technology has already demonstrated significant improvements in motor scores for patients with Parkinson’s disease as evidenced by the interim results from our VANTAGE multicenter clinical trial,” said Maulik Nanavaty, president, of neuromodulation at Boston Scientific. “With this approval we look forward to extending the use of this technology to improve the quality of life of patients with dystonia.”

The Vercise DBS System received CE Mark and Australia Therapeutic Goods Administration approval in 2012 for the treatment of Parkinson’s disease. It is available in Europe, Israel, Australia and Colombia for this indication. In the United States, the Vercise DBS System is investigational and not available for use or sale.

Further bolstering its portfolio of peripheral embolization technologies, Boston Scientific also received U.S. Food and Drug Administration 510(k) clearance and CE mark approval for its Direxion torqueable microcatheter.

Peripheral embolization is a technique used primarily by interventional radiologists to treat liver cancer, uterine fibroids and other challenging conditions. It involves deliberately blocking a blood vessel to prevent blood flow to an area of the body, which can effectively shrink a tumor or block an aneurysm.

“The Direxion microcatheter’s unique handling characteristics are intended to enable physicians to efficiently access difficult to navigate vessels across many types of peripheral embolization procedures,” said Riad Salem, M.D., professor of radiology and director of interventional oncology at Northwestern Memorial Hospital.

“Combined with a range of tip shape offerings and selection of pre-loaded systems, the Direxion microcatheter offers an attractive portfolio that opens up a whole new dimension in microcatheter technology,” said Robert Lewandowski, M.D., associate professor of radiology at Northwestern Memorial Hospital.

Salem and Lewandowski were the first users of this platform worldwide.

The Direxion torqueable microcatheter is designed to facilitate selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature. The product, offered in either a 0.021” or 0.027” inner diameter microcatheter, features a slotted, nitinol hypotube technology. This technology is designed to maximize torque transmission in the catheter shaft. The device is available in six tip configurations as well as pre-loaded configurations designed to suit a range of peripheral embolization procedures.