Boston Scientific Corporation (NYSE: BSX) announces U.S. Food and Drug Administration (FDA) approval of the Infinion™ 16 Percutaneous Lead for its Precision Plus™ Spinal Cord Stimulator (SCS) System, the first rechargeable SCS device for chronic pain management. The Infinion 16 Lead is the world's first and only 16-contact percutaneous lead and the latest innovation in Boston Scientific's comprehensive percutaneous lead portfolio. The Company is introducing the Infinion 16 Lead at the North American Neuromodulation Society (NANS) meeting, which begins today in Las Vegas.
SCS leads are designed to deliver electrical pulses from an implantable pulse generator to the spinal cord to mask pain signals to the brain. Until now, percutaneous leads have offered a maximum of eight stimulating contacts. By providing twice the number of contacts than any previous percutaneous lead, the Infinion 16 Lead is designed to offer more coverage of the spinal cord for the management of chronic pain.
"When a single percutaneous lead is the best choice for my patient, the Infinion 16 Lead is a useful new option that lets me cover more of the spinal cord than ever before," said Marshall Bedder, M.D., Director of Interventional Pain at Pacific Medical Centers in Seattle. "For the first time, I can now place 16 contacts through a single, small insertion needle with just one lead placement."
"The Infinion 16 Lead is the latest advance in lead technology and an exciting new addition to our unrivaled percutaneous lead portfolio," stated Maulik Nanavaty, Senior Vice President and President of Boston Scientific's Neuromodulation Division. "With the launch of the Infinion 16 Lead, Boston Scientific continues its commitment to innovation by offering pain management physicians more choices to help optimize pain relief for their patients."
SCS evaluation device to be discussed at NANS
At the NANS conference, several pain management physicians will discuss their clinical use of Boston Scientific's Observational Mechanical Gateway (OMG™) Connector. The OMG Connector is a novel device designed to allow patients with a failed or sub-optimal SCS trial to evaluate Boston Scientific's Precision Plus System with SmoothWave™ Technology as an alternative therapy.
"Switching to another drug when the first one fails to deliver the desired patient benefit is standard medical practice," said Michael Stanton-Hicks, M.D., Vice-Chairman of the Anesthesiology Institute at the Cleveland Clinic. "The OMG Connector now gives me that capability with my SCS trial patients."
"The OMG device has enabled me to treat patients using SCS in certain instances where those patients failed trials using other SCS systems," said Stephen Pyles, M.D., of the Florida Pain Clinic in Ocala. "The OMG is a tool SCS practitioners should use to provide their SCS patients with every opportunity for success."
Examining how pain could play a direct protective role in the gut