Boston Scientific Receives FDA Approval of New Clik (BSX)

Boston Scientific Corporation BSX today announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Clik™ Anchor for its Precision Plus™ Spinal Cord Stimulator (SCS) System, the world's first rechargeable SCS device for chronic pain management. The Clik Anchor features an innovative locking system designed to improve lead anchoring speed and consistency. Locking into place on the lead with a simple turn of a hex wrench, it provides tactile and audible confirmation for physicians that the lead is secured. The Company is introducing the Clik Anchor at the American Academy of Pain Medicine Annual Meeting, which begins today in Washington, D.C. "The Clik Anchor is easy to use and gives me confidence that the lead is secure," said Salim Hayek, M.D., Ph.D., of the University Hospitals Case Medical Center in Cleveland, Ohio. "This new product will benefit my patients and my practice with simpler, more consistent lead anchoring." According to the National Center for Health Statistics, pain is the most common reason Americans seek medical treatment, and an estimated 26 million Americans experience frequent back pain. Tens of thousands of patients with chronic pain have found that SCS systems help them manage their pain. Spinal Cord Stimulation is a reversible therapy that manages pain through an implantable pulse generator and external devices that control therapy and charge an implant. Boston Scientific's Precision Plus SCS System, powered by SmoothWave™ Technology, masks pain signals by delivering independently controlled pulses of electricity through SCS leads. Anchors are designed to secure leads and minimize unwanted migration. "With approval and launch of the Clik Anchor, we have added six new products to our Neuromodulation portfolio in the past year," said Michael Onuscheck, Senior Vice President and President of Boston Scientific's Neuromodulation Division, a leader in microelectronic implantable technologies used to treat chronic neuropathic pain. "The Clik Anchor complements our SCS percutaneous leads portfolio, and gives physicians the most comprehensive array of lead options in the market." The Precision Plus SCS System is indicated as an aid in managing chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. For more information, visit www.ControlYourPain.com.