Medtronic gains approval, launches Tyrx antibacterial envelope in Europe

Medtronic's Tyrx Absorbable Antibacterial Envelope--courtesy of Medtronic

Already cleared by the FDA last year, the Tyrx Absorbable Antibacterial Envelope has won a CE mark for use with cardiac devices, and Medtronic ($MDT) has launched it in Europe. The medical device giant acquired startup Tyrx in January for $159 million up front; the bioresorbable product was approved by the FDA in December for use with implantable neuromodulator devices.

Tyrx shareholders stand to gain another $40 million in development-based milestones as well as an amount equivalent to fiscal 2015 and 2016 annual revenue growth for Tyrx products, according to Medtronic's latest quarterly SEC filing. Tyrx investors include HLM Venture Partners, Clarus Ventures and Pappas Ventures.

Medtronic hasn't divulged much yet about the performance of Tyrx products, but it did say that between the Cardiocom and Tyrx acquisitions they added $19 million in revenue during the last quarter. FDA also approved a first-generation, partially-resorbable version of the product for use with spinal cord neurostimulators.

Although the rate of infection for these procedures is relatively low, the envelope reduces them further. For the non-absorbable version of the antibacterial envelope, a study found that only 0.2% of patients who received the envelope during surgeries for an implantable cardioverter-defibrillator or a cardiac resynchronization therapy replacement device. Those who did not receive the envelope had a 1.9% infection rate. This study involved 1,000 patients over 55 sites in the U.S.

The absorbable Tyrx envelope releases rifampin and minocycline to the surgical site to help prevent infection. It dissolves and is fully absorbed about nine weeks after implantation.

"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," Dr. Charles Kennergren of Sahlgrenska University Hospital in Gothenburg, Sweden, said in a statement. "We have high expectations for this novel product, both in terms of reducing infection rates as well as avoiding device migrations." He recently performed the first implant of the envelope in Europe.

- here is the release

Special Report: FierceMedicalDevices' 2012 Fierce 15 - Tyrx

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