Medtronic Alters ECMO Therapy on New FDA Rules for Coronavirus

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Medtronic plc MDT recently announced the temporary use of several of its cardiopulmonary technologies for Extracorporeal Membrane Oxygenation (ECMO) therapy for more than six hours in the United States. This announcement comes on the heels of the issuance of the FDA’s new guidelines released on Apr 6, 2020, in response to the coronavirus pandemic.

This new set of rules allows temporary limited modifications to the indications of certain FDA-cleared or FDA-approved cardiopulmonary devices without prior submission of premarket notification.

Significance of the Modification

Per the guidance, Medtronic’s devices like the Bio-Console 560 Extracorporeal Blood Pumping Console with Accessories, Affinity CP Adapter and Affinity Centrifugal Blood Pumps can now be used for more than six hours in an ECMO circuit for the treatment of patients currently experiencing acute respiratory/cardiopulmonary failure due to the COVID-19 infection.

With the latest development in its cardiopulmonary technologies, Medtronic aims to strengthen its Minimally Invasive Therapies Group in the face of the ongoing crisis in the United States.

However, the limited indication modification for ECMO therapy exceeding six hours has not been approved by the FDA. Further, this limited approval will be in effect only for the duration of the public health emergency arising from COVID-19, as declared by the Department of Health and Human Services.

Industry Prospects

Per a report by Reports and Data published on GlobeNewswire, the global ECMO market was valued at $267.1 million in 2019 and is expected to reach $371.8 million by 2027, witnessing a CAGR of 4.2%. Factors like rising prevalence of target diseases, technological advancements and increasing ECMO centers are likely to drive the market.

Given the market potential, the limited modification post the latest FDA guidance is a welcome move during the pandemic.

Recent Developments to Handle Health Issues During the Pandemic

Of late, Medtronic has been adopting several measures to combat any health crisis during the ongoing public health emergency.

In April, the company announced that it mobilized its global resources to cater to patients and physicians’ requirements, including an expansion in the production and distribution of critical products to combat the COVID-19.

Further, in April, the company announced the ramping up of its ventilator production and collaborations with technology partners and governments to drive ventilator innovation and production to cater to COVID-19 patients across the globe.

Notably, Medtronic received Emergency Use Authorization from the FDA for its Puritan Bennett 560 (PB560) ventilator, which will soon be available in the United States. Further, the company is currently in limited market release of a latest remote management capability for its Puritan Bennett 980 (PB980) ventilator with two hospitals in the United States.

In March, the company announced that two new solutions designed to help assess, monitor and triage support for patients who may be concerned about COVID-19 and their respiratory symptoms are being launched by its Medtronic Care Management Services (MCMS) business.

Further, a new Respiratory Infectious Disease Health Check to existing MCMS customers has already been launched. It is currently on track to launch a new COVID-19 Virtual Care Evaluation and Monitoring solution available to U.S. health systems, health plans and employers.

Price Performance

Shares of the company have gained 4.1% in the past year compared with the industry’s 4.8% growth and the S&P 500’s 11.4%.



 

Zacks Rank & Stocks to Consider

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

Some better-ranked stocks from the broader medical space are Aphria Inc. APHA, Surmodics, Inc. SRDX and Owens Minor, Inc. OMI.

Aphria’s long-term earnings growth rate is projected at 24.6%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Surmodics’ long-term earnings growth rate is estimated at 10%. The company presently sports a Zacks Rank #1.

Owens Minor’s long-term earnings growth rate is estimated at 8.3%. It currently carries a Zacks Rank #2.

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