Medtronic TYRX Driveline Gets FDA's Breakthrough Designation

Recently Medtronic plc’s MDT TYRX Absorbable Antibacterial Driveline Wrap gained Breakthrough Device Designation. This designation ensures that patients will gain timely access to this product, which is considered to have the potential to provide more effective treatment or diagnosis for this life-threatening or irreversibly debilitating cardiovascular disease, by speeding up all relevant regulatory procedures.

In this regard, the FDA is going to provide Medtronic priority review and interactive communication regarding device development through commercialization decisions. We note that the TYRX Driveline Wrap device is currently in early-stage research and development and not available anywhere.

This development will help Medtronic to augment its research work in the space of interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

TYRX Driveline at a Glance

The TYRX Absorbable Antibacterial Driveline helps in securely holding a percutaneous driveline on patients getting implanted with a ventricular assist device (VAD). Going by Mayo Clinic’s definition, VAD (also known as a mechanical circulatory support device) is an implantable mechanical pump that helps pump blood from the lower chambers of the heart (the ventricles) to the rest of the body. A VAD is used in people who have a weakened heart or heart failure.

The driveline in this regard acts as a vital component of VAD systems. It connects the implanted heart pump with an external controller. The pump increases the amount of blood that circulates through the body in advanced heart failure patients.

However, this driveline extends outside the body and as a result is prone to infection. To check these complications, Medtronic’s TYRX technology platform will prove to be useful. Currently utilized in the TYRX Absorbable Antibacterial Envelope, this is constructed from a multifilament, knitted absorbable mesh, and releases antimicrobial agents, minocycline and rifampin, over a minimum of seven days.

The TYRX Absorbable Antibacterial Envelope is fully absorbed by the body approximately nine weeks after implantation, and stabilizes a cardiac implantable electronic device (CIED) such as a pacemaker or implantable defibrillator or an implanted neurostimulator.

Industry Prospects

Per a report by Mordor Intelligence, the cardiovascular devices market is expected to witness a CAGR of 6.3% between 2019 and 2024. Factors like the increasing incidence of cardiovascular diseases and growing elderly population are expected to drive the market.

Given the market potential, the latest development is well-timed.

Recent Developments in this Space

Last week, Medtronic announced the latest data from its Worldwide Randomized Antibiotic Envelope Infection (WRAP-IT) Trial, which illustrated the cost-effectiveness of TYRX Absorbable Antibacterial Envelope (TYRX Envelope). The data demonstrated that TYRX Envelope is economical for use in patients at increased risk of infections who receive cardiac implantable electronic devices (CIEDs) unlike the standard-of-care infection prevention strategies in the U.S. healthcare system.

The company also received the FDA’s go-ahead in September to begin an early feasibility study of the Intrepid Transcatheter Tricuspid Valve Replacement system in patients with severe symptomatic tricuspid regurgitation.

In August, Medtronic announced two trial results, which illustrated the superiority of the Arctic Front Advance Cardiac Cryoballoon and Freezor MAX Cardiac CryoAblation Catheter for the first-line treatment (prior to drug therapy) of recurrent symptomatic paroxysmal atrial fibrillation.

Further, in the same month, Medtronic’s Evolut Transcatheter Aortic Valve Replacement system won the FDA’s approval for revised commercial labeling.

Price Performance

Shares of Medtronic have lost 5% in the past year compared with the industry’s 3.7% dip.

Zacks Rank & Key Picks

Currently, Medtronic carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are QIAGEN N.V. QGEN, Thermo Fisher Scientific Inc. TMO and Hologic, Inc. HOLX.

QIAGEN’s long-term earnings-growth rate is estimated at 22.3%. It currently sports a Zacks Rank #1. (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Thermo Fisher’s long-term earnings-growth rate is estimated at 15%. It currently carries a Zacks Rank #2 (Buy).

Hologic’s long-term earnings-growth rate is estimated at 15.5%. The company presently sports a Zacks Rank #1.

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