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Medtronic Receives FDA's Go Ahead for EFS Study on TTVR

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Medtronic plc (MDT - Free Report) recently received FDA approval to begin an early feasibility study (“EFS”) of the Intrepid Transcatheter Tricuspid Valve Replacement (“TTVR”) system in patients with severe symptomatic tricuspid regurgitation. The initiation of the EFS comes on the heels of the receipt of the Breakthrough Device Designation from the FDA for the Intrepid TTVR System.

For investors’ note, the Intrepid TTVR system is used as an investigational device across the globe. Also, the Intrepid transcatheter valve is the same valve which is being evaluated for the treatment of symptomatic mitral-valve regurgitation in the transfemoral mitral EFS.

The beginning of the study, along with the receipt of the designation, is expected to be a step forward for Medtronic to strengthen its Coronary & Structural Heart business, which is a component of the broader Cardiac and Vascular Group.

Significance of the EFS Initiation

Tricuspid regurgitation is a condition in which the diseased, damaged or malfunctioning tricuspid valve allows blood to flow back into the heart's upper-right chamber. This can lead to eventual heart failure and even death.

Per the medical fraternity associated with the study, patients with tricuspid valve regurgitation constitute a significant patient population who are suffering from heart-valve diseases currently. The study is expected to pave the way for potential future treatment of such patients. Although much progress has been made vis-à-vis transcatheter replacement of diseased aortic valves, the study regarding the feasibility of replacing the tricuspid valve without open-heart surgery represents a new dimension in cardiology.

Notably, the clinical experience generated during the initial study phase will play an important role in the decision regarding the future of the therapy. This is so because many of these patients are not suitable candidates for traditional surgical tricuspid valve interventions due to their poor right-heart functions. Such patients are also at a higher risk due to co-morbidities. The panel associated with the EFS also believes that the early results will lead to more clinical research and device innovation regarding this treatable disease.

Industry Prospects

Per a report by Global Market Insights, the global transcatheter heart-valve replacement market was valued over $4.2 billion in 2018 and is expected to register a CAGR of 14% between 2019 and 2025. Factors like growing technological advancements and increasing incidents of cardiac-valve disorders are likely to drive the market.

Given the market potential, the study’s outcome is expected to significantly strengthen Medtronic’s business.

Recent Developments in Cardiac and Vascular Group

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

The company, in August, 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.

In July, the company received the FDA’s approval and CE Mark for its LINQ II insertable cardiac monitor with remote programming. In the same month, Medtronic announced the start of a prospective, observational, global, multi-center, real-world, post-market study to assess the safety and effectiveness of the Valiant Navion Thoracic Stent Graft System for the treatment of thoracic aortic dissection.

Price Performance

Shares of the company have lost 3.9% compared with the 3.3% fall of the industry and 12% 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 - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and Hologic, Inc. (HOLX - Free Report) .

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%. 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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