FDA gives nod to St. Jude's CRT-D system and pacing lead

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

The FDA has given the green light to St. Jude Medical’s Unify Quadra cardiac resynchronization therapy defibrillator (CRT-D) and Quartet left ventricular quadripolar pacing lead.

Unify Quadra and Quartet help with the management of heart failure patients by integrating TailoredTherapy features, which assist during the implantation and follow-up periods. TailoredTherapy also helps manage pacing complications. The platform is approved for remote patient management using the Merlin.net Patient Care Network, according to St. Paul, Minn.-based St. Jude.

The Quartet lead features four electrodes spaced over 4.7 centimeters, enabling up to 10 pacing configurations. The quadripolar pacing electrodes can help optimize CRT performance such as pacing around the scar, which can help avoid complications.

Additionally, the Quartet pacing lead is built on the QuickFlex µ lead platform, which features Optim insulation that combines the biostability and flexibility of silicone rubber.

Based on the approval, St. Jude said that it will begin shipping the products immediately.