Medtronic’s Absorbable Envelope for Implantable Cardiac Devices Gets CE Mark

Medtronic Inc. received CE mark for the TYRX Absorbable Antibacterial Envelope—a mesh envelope that covers an implantable cardiac device to help stabilize the device after implantation and reduce surgical-site infections.

The efficacy of the previous generation, non-absorbable TYRX Antibacterial Envelope* has been shown in three published studies, with new six-month follow-up data from the CITADEL/CENTURION study presented at Cardiostim 2014. Six months following implantation, patients who received a single- or dual- chamber implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) replacement device with a TYRX Antibacterial Envelope experienced lower infection rates than a historical cohort of patients who were implanted without the envelope.

Specifically, according to figures cited by Medtronic, infection occurred in 0.2 percent of patients who received the envelope during an ICD or CRT implant, compared to 1.9 percent of patients who did not receive the envelope (p<0.001). Additionally, the rate of device mechanical complications was low (4.0 percent) in patients who received the envelope.

CITADEL/CENTURION is a multi-center study involving 55 sites in the United States that prospectively treated more than 1,000 patients undergoing an ICD or CRT replacement with the TYRX Antibacterial Envelope. The primary endpoints were major infection (involving any site other than skin or subcutaneous tissue of the incision or endocarditis) and device mechanical complication.

“The TYRX envelope seems to offer physicians a simple, yet highly effective method of reducing surgical-site infections, particularly among those high-risk patients who are undergoing a repeat procedure,” said Charles Kennergren, M.D., Ph.D., Sahlgrenska University Hospital, Gothenburg, Sweden. “We have high expectations for this novel product, both in terms of reducing infection rates as well as avoiding device migrations.”

Kennergren recently performed the first implant of the envelope in Europe.

The TYRX Absorbable Antibacterial Envelope, covering a cardiac implantable electronic device such as a pacemaker, ICD or CRT device, releases rifampin and minocycline to the surgical site to help prevent infection. The envelope stabilizes the implanted device, then dissolves and is fully absorbed approximately nine weeks after implantation. The TYRX Absorbable Antibacterial Envelope is currently cleared for use in the United States and approved in Canada and Israel.

Medtronic acquired New Jersey-based TYRX in January 2014 for $160 million in cash, not including future milestone payments.

“While the risk of infection is low for most patients receiving an implantable device, the TYRX envelope offers an extra layer of protection,” said John Liddicoat, M.D., president of the Cardiac Rhythm and Heart Failure business and senior vice president of Medtronic. “The TYRX envelope provides physicians with a proven solution to make implantable device procedures safer for their patients.”

Medtronic is based just outside Minneapolis in Fridley, Minn.