Advertisement
UK markets close in 2 hours 57 minutes
  • FTSE 100

    7,956.67
    +24.69 (+0.31%)
     
  • FTSE 250

    19,867.29
    +56.63 (+0.29%)
     
  • AIM

    743.20
    +1.09 (+0.15%)
     
  • GBP/EUR

    1.1691
    +0.0022 (+0.19%)
     
  • GBP/USD

    1.2640
    +0.0002 (+0.01%)
     
  • Bitcoin GBP

    56,136.34
    -575.30 (-1.01%)
     
  • CMC Crypto 200

    885.54
    0.00 (0.00%)
     
  • S&P 500

    5,246.77
    -1.72 (-0.03%)
     
  • DOW

    39,838.46
    +78.38 (+0.20%)
     
  • CRUDE OIL

    82.43
    +1.08 (+1.33%)
     
  • GOLD FUTURES

    2,232.40
    +19.70 (+0.89%)
     
  • NIKKEI 225

    40,168.07
    -594.66 (-1.46%)
     
  • HANG SENG

    16,541.42
    +148.58 (+0.91%)
     
  • DAX

    18,494.40
    +17.31 (+0.09%)
     
  • CAC 40

    8,227.52
    +22.71 (+0.28%)
     

Medtronic (MDT) Gets FDA Nod to Study Intrepid TMVR System

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.

ADVERTISEMENT

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.

Market Prospects

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.

Recent Developments

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.

Price Performance

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%.

Today's Best Stocks from Zacks

Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2018, while the S&P 500 gained +15.8%, five of our screens returned +38.0%, +61.3%, +61.6%, +68.1%, and +98.3%.

This outperformance has not just been a recent phenomenon. From 2000 – 2018, while the S&P averaged +4.8% per year, our top strategies averaged up to +56.2% per year.

See their latest picks free >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Medtronic PLC (MDT) : Free Stock Analysis Report
 
Haemonetics Corporation (HAE) : Free Stock Analysis Report
 
NuVasive, Inc. (NUVA) : Free Stock Analysis Report
 
Amedisys, Inc. (AMED) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research