FDA OKs Boston Scientific Splitters - Analyst Blog


Boston Scientific’s (BSX) two spinal cord stimulation (SCS) lead splitters have been reportedly cleared by the FDA. The company will unveil the approved SCS splitters at the annual meeting of the American Society of Interventional Pain Physicians (ASIPP) being held from June 26 – 30, 2010, in Arlington, Virginia.
 
The new lead splitters (W4 and D4) have been designed for use with Boston Scientific’s Precision Plus SCS System, the first-of-its-kind device for treating chronic pain of the trunk, back and/or limbs.
 
Chronic pain is a debilitating condition that affects roughly 50 million people in the U.S. The annual cost associated with this condition has been estimated at $100 billion. Chronic pain, which is long lasting or recurring, is common in several back and spine conditions and is often misdiagnosed. Poor prognosis of chronic back/spinal pain typically leads to treatment failure.   
 
SCS, an implantable neurostimulation (stimulation of the spinal cord by electrical impulses) therapy, has a proven track record in providing pain relief to patients and is primarily used for chronic pain management when physical and/or drug therapies are ineffective. Precision Plus, a novel neurostimulation device, enables physicians to offer tailor-made therapies for patients.
 
Boston Scientific’s new splitters enable multi-site placement of up to four spinal cord leads (a part of SCS system), which deliver electrical pulses that interrupt pain signal transmission to the brain, thereby offering relief. This further improves the Precision Plus system, offering more options for the physicians in treating patients with chronic pain.
 
Boston Scientific manufactures medical devices and products used in a broad range of interventional medical specialties. In the neurostimulation device space, the company faces stiff competition from Medtronic (MDT), St. Jude Medical (STJ) and Cyberonics (CYBX).
 
The neurostimulation market is growing at a healthy pace, driven by growth in age-related neurological conditions and significant need for effective alternative therapies. The U.S. market for neurostimulation products was valued at $1.3 billion in 2009 with SCS systems capturing the largest share (roughly 40%). This market is projected to grow 16% annually over the next five years, offering a lucrative opportunity for the incumbent players.  

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