Medical device major Medtronic, Inc. (MDT) has won the CE (Conformité Européenne) Mark for its TYRX Absorbable Antibacterial Envelope that is designed to contain a pacemaker pulse generator or a defibrillator in a sterile environment at the time of implantation. This innovative envelope is made from multifilament knitted mesh coated with an absorbable polyarylate polymer.
A product labeled with a CE Mark implies that it can be sold anywhere within the European Economic Area (EEA). With the TYRX Envelope System winning the CE Mark, Medtronic will now be able to gain a considerable share in the cardiovascular product market in Europe.
The TYRX Absorbable Antibacterial Envelope has been devised to cover a cardiac implantable electronic device (CIED) such as a pacemaker, ICD or CRT device, in order to offer a stable environment when it is implanted into a patient's body. This sterile prosthesis consists of antimicrobial agents – rifampin and minocycline. During implantation, it releases these agents at the surgical site to help prevent infection.
The envelope stabilizes the CIED, and then dissolves and is fully absorbed approximately nine weeks after implantation.
Earlier, six-month follow-up data from the CITADEL/CENTURION Study had demonstrated the effectiveness of the previous generation of this prosthesis – a non-absorbable TYRX Antibacterial Envelope. The study results indicated that only 0.2% of the patients who received the envelope during a CIED implant caught an infection. This compared favorably to 1.9% of patients who suffered an infection in the absence of the prosthesis.
Moreover, the rate of device-related mechanical complications was also observed to be low in case of patients who received this non-absorbable envelope. Per management, in CIED implanted patients, who are at low risk of infection mostly, the TYRX envelope provides an additional protective layer and eases a physician's task to provide a safer implantation procedure.
N.J.-based TYRX was an FDA registered medical device manufacturer of drug-device combination products utilizing novel polymer technology. In Jan 2014, Medtronic acquired TYRX for an initial payment of $160 million plus potential earn out and performance based milestone payments.
Currently, the TYRX Absorbable Antibacterial Envelope is approved for use in Canada and Israel, and also hold clearance in the U.S.
Medtronic's oldest and largest segment – Cardiac Rhythm & Heart Failure – which incorporates this absorbable mesh envelope, had delivered positive growth of 4% in the last reported quarter. More importantly, this growth incorporated combined revenues of $19 million earned from the company's acquisition of TYRX and Cardiocom.
We believe that with the receipt of this CE Mark for the absorbable TYRX envelope, Medtronic has achieved yet another milestone with respect to its enriched portfolio of cardiovascular products. The technology reinforces the company's commitment toward improving patient outcomes by reducing implant-related infections.
Currently, Medtronic carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical products industry include ICU Medical, Inc. (ICUI), Abaxis, Inc. (ABAX) and Conatus Pharmaceuticals Inc. (CNAT). While ICU Medical sports a Zacks Rank #1 (Strong Buy), both Abaxis and Conatus hold a Zacks Rank #2 (Buy).
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