Medtronic plc MDT received FDA permission to initiate an early feasibility study (EFS) for its Intrepid transcatheter mitral valve replacement (TMVR) system, which uses a minimally-invasive transfemoral access approach.
The regulatory nod comes following the company achieving favorable primary endpoint outcomes of the Intrepid TMVR pilot study, using the transapical approach. This is the first-ever trial to receive the FDA’s approval to assess the safety and proficiency of a TMVR system.
The development is expected to strengthen Medtronic’s position within the TMVR space. The TMVR business accounts for a major part of the company’s structural heart business.
More About the EFS and the Intrepid TMVR system
The prospective, multi-center, non-randomized EFS will examine the safety and efficacy of the Intrepid TMVR System with the transfemoral approach in patients with critical symptomatic mitral regurgitation (MR), particularly those who are ineligible for conventional mitral valve surgery.
The study plans to enroll and treat up to 15 patients, who need mitral valve treatment, at up to six centers. Treated patients will be followed up at one, three, six and 12 months, and every six months thereafter through five years. Results of this EFS study will lead to the development of next-generation transfemoral TMVR technologies.
The transfemoral approach for mitral valve replacement is a less invasive approach than the transapical technologies currently in pivotal trials.
The Intrepid TMVR system is available for investigational use only and it is not permitted anywhere outside of clinical studies.
Per Market Watch, the global transcatheter mitral valve replacement market was worth $380 million in 2018 and it is anticipated to reach $31.40 billion by 2025 end, witnessing a CAGR of 30.1% between 2019 and 2025.
Lately, Medtronic has been investing in several developments to strengthen the structural heart business.
In September 2019, the company received the FDA clearance and launched the Evolut PRO+ TAVR System — a new-generation Medtronic TAVR system that leverages the self-expanding, supra-annular Evolut TAVR platform — in the United States. The launch followed the FDA’s approval for the Evolut TAVR platform in treating patients with symptomatic severe aortic stenosis at low risk of surgical mortality.
As part of its strategy toward developing solutions for the treatment of valve disease, Medtronic is sponsoring and currently enrolling patients to the breakthrough APOLLO trial. The trial is designed to study the safety and performance of the Intrepid system in treating MR.
In the past one year, the company has outperformed its industry. The stock has rallied 7.8% against the industry’s 2.5% decline.
Zacks Rank and Other Key Picks
Medtronic currently has a Zacks Rank # 2 (Buy).
A few other top-ranked stocks in the broader medical space are Haemonetics HAE, NuVasive NUVA and Amedisys AMED, each presently carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Haemonetics’ long-term earnings growth rate is expected to be 13.5%.
NuVasive’s long-term earnings growth rate is projected at 10.9%.
Amedisys’ long-term earnings growth rate is expected to be 16.26%.
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