Boston Scientific Announces FDA Clearance of New Heart Failure Lead Delivery System
NATICK, Mass., May 13 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration clearance of the ACUITY Break-Away™ Lead Delivery System for use with cardiac resynchronization therapy defibrillators (CRT-Ds) and cardiac resynchronization therapy pacemakers (CRT-Ps), both of which treat heart failure.
Leads are insulated wires that carry heart signals to the implanted device and deliver energy from the device to the heart. Leads are inserted into the heart through veins with a lead delivery system. The ACUITY Break-Away Lead Delivery System is designed to place leads in veins of varying sizes, including difficult-to-access veins.
Key features of the ACUITY Break-Away™ Lead Delivery System include:
- An integrated, break-away hemostasis valve designed to minimize blood loss and allow for a streamlined implant experience with fewer steps and instruments used during surgery
- The smallest inner catheter lead delivery on the market enables physicians to deliver a 4 French lead
- Seven outer and two inner guide catheter shapes designed to deliver the lead in a variety of anatomies
"Boston Scientific continues its long tradition of innovation with the introduction of the ACUITY Break-Away Lead Delivery System, which is designed to simplify the implant experience for both patients and physicians," said Kenneth Stein, M.D., Chief Medical Officer, CRM, for Boston Scientific's Cardiology, Rhythm and Vascular Group. "Physicians can use this lead delivery system in combination with our broad range of left ventricular leads, which have a 97 percent implant success rate(1)."
Boston Scientific's left ventricular leads include four designs that provide multiple options for securing the lead to the heart. This lead portfolio also features Electronic Repositioning™, which provides physicians with six configurations for stimulating the left side of the heart even after implant, potentially avoiding an additional surgical procedure.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
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(1) Based on ACUITY® Spiral Lead, EASYTRAK® 3 Lead and ACUITY® Steerable Lead clinical studies.