Medtronic's (MDT) TYRX Envelope Study Results Encouraging

Medtronic plc MDT 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 latest data demonstrates that the 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.

This analysis has been published in Circulation: Arrhythmia and Electrophysiology.

Additionally, long-term results from the WRAP-IT Trial illustrates that the effects of TYRX to reduce major CIED infection were sustained through three years of follow-up, which was driven by a significant reduction in pocket infections. The results of this study were published in Heart Rhythm.

The favorable study outcome for Medtronic’s TYRX Envelope is expected to strengthen its foothold in the global Cardiac Rhythm & Heart Failure business. For investors’ note, the Cardiac Rhythm & Heart Failure arm is a component of the company’s broader Cardiac and Vascular Group.

Few Words on the TYRX Envelope

The TYRX Envelope is an absorbable single-use device that holds a CIED or implanted neurostimulator and is designed to stabilize the device after implantation while releasing antimicrobial agents over a minimum of seven days. The envelope is fully absorbed by the body, approximately nine weeks after implantation. The device has a one-year shelf life in the United States, Canada, Australia and New Zealand.

Notably, Medtronic won the CE Mark for its TYRX Envelope in 2014.

Significance of the Study Outcomes

The first outcome of the WRAP-IT study, which focused on the cost-effectiveness of TYRX Envelope, compared costs and patient outcomes between patients who received the TYRX Envelope and patients who received standard-of-care. Cost-effectiveness analyses, which are tools to indicate which interventions provide good value for money, demonstrated that the TYRX Envelope is cost-effective in the WRAP-IT patient population as its incremental cost-effectiveness ratio is well below the upper willingness-to-pay threshold of $150,000.

For investors’ note, $150,000 is the recommended threshold of the American College of Cardiology/American Heart Association practice guidelines on cost/value methodology.

Per the medical fraternity associated with the study, this analysis builds upon the results of the WRAP-IT study which proved that the use of the antibiotic envelope leads to a significant reduction in infections with no increase in complications.

Per management, the TYRX Envelope leads to value addition by reducing readmission rates, lowering infection risk and decreasing hospitalizations. Given the pandemic situation, reduction of exposure risks of both patients and physicians is of utmost importance.

The other study result also establishes the ability of the TYRX Envelope to reduce major CIED infection through sustained follow-ups for three years.

Industry Prospects

Per a report by Markets And Markets, the global cardiac monitoring & cardiac rhythm management devices market is projected to reach a worth of $26.8 billion by 2025 from $22.1 billion in 2020, at a CAGR of 4%. Factors like increasing incidence of cardiovascular diseases and availability of innovative products are likely to drive the market.

Given the market potential, the trial results are expected to boost Medtronic’s business significantly.

Recent Developments in Cardiac and Vascular Group

Of late, Medtronic has been witnessing a slew of developments in this business arm.

The company received the FDA’s approval this month 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.

In the same month, the company published a favorable outcome of the IN.PACT arteriovenous (“AV”) Access trial in The New England Journal of Medicine, which demonstrates that the IN.PACT AV drug-coated balloon leads to fewer disruptions in dialysis therapy.

Price Performance

Shares of the company have lost 2.9% in the past year versus the 3% fall of the industry and 11.3% rise of the S&P 500.

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 flaunts 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 15.5%. It currently carries a Zacks Rank #2 (Buy).

Hologic’s long-term earnings-growth rate is estimated at 16.4%. The company presently sports a Zacks Rank #1.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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