Advertisement Boston Scientific Acuity Break-Away Lead Delivery System Receives FDA Clearance - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Boston Scientific Acuity Break-Away Lead Delivery System Receives FDA Clearance

Boston Scientific has received FDA clearance for the Acuity Break-Away Lead Delivery System for use with cardiac resynchronisation therapy defibrillators (CRT-Ds) and cardiac resynchronisation therapy pacemakers (CRT-Ps), both of which treat heart failure.

Boston Scientific said that 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.

The key features of the Acuity Break-Away Lead Delivery System are an integrated, break-away hemostasis valve designed to minimise blood loss and allow for a streamlined implant experience with fewer steps and instruments used during surgery, smallest inner catheter lead delivery on the market that enables physicians to deliver a 4 French lead and seven outer and two inner guide catheter shapes designed to deliver the lead in a variety of anatomies.

Boston Scientific claimed that its left ventricular leads include four designs that provide multiple options for securing the lead to the heart. The 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.

Kenneth Stein, chief medical officer of CRM for cardiology, rhythm and vascular group at Boston Scientific, said: “Boston Scientific’s Acuity Break-Away Lead Delivery System is designed to simplify the implant experience for both patients and physicians.

“Physicians can use this lead delivery system in combination with our broad range of left ventricular leads, which have a 97% implant success rate.”