Medtronic's Evolut TAVI Gets CE Mark for Low-Risk Patients

Medtronic’s MDT Evolut Transcatheter Aortic Valve Implantation (TAVI) system recently gained CE (Conformité Européenne) Mark for patients with severe native aortic stenosis (AS) who are at a low risk of surgical mortality. This regulatory go-ahead has been followed by the European commercial launch of the same.

In addition, the Evolut TAVI platform also received a new indication approval that enables treatment of patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.

With the latest development, Medtronic aims to strengthen its Coronary & Structural Heart segment globally. Notably, the Coronary & Structural Heart segment is part of the company’s broader Cardiac and Vascular Group.

What is Aortic Stenosis?

Aortic stenosis refers to a serious medical condition wherein one’s aortic valve narrows. It can cause cardiac arrest and even death, if left untreated. Aortic valve replacement is a standard procedure to treat such patients. However, those at risk of open-heart surgery can instead be treated with transcatheter heart valve (THV) implantation of a device like Evolut using a less-invasive procedure.

A Brief Note on Evolut TAVI Approval

The latest expanded low-risk indication approval is based on clinical data from the global, prospective, randomized, multi-center Evolut Low Risk Trial. This trial evaluated three valve generations (CoreValve, Evolut R and Evolut PRO) against Surgical aortic valve replacement (SAVR). The study, which covered more than 1,400 patients, showed that TAVI can have a better safety profile and be an effective treatment option in low-risk patients with shorter hospitals stays and improved 30-day quality-of-life scores compared to SAVR.

Per the study outcome, the Evolut system shows a lower rate of the composite of all-cause death or disabling stroke with TAVI at 30 days. It also demonstrated superior hemodynamic (blood flow) performance with significantly lower mean aortic valve gradients and larger EOAs (effective orifice area) compared to surgery at one year.

Industry Prospects

Per a report by Mordor Intelligence, the cardiovascular devices market is expected to witness CAGR of 6.3% between 2019 and 2024. Factors like increasing incidence of cardiovascular diseases and growing geriatric population are expected to drive the market further.

Given the market potential, the latest regulatory approval can be considered well timed.

Recent European Regulatory Approvals in Cardiac & Vascular

Of late, Medtronic has been witnessing a series of developments in its Cardiac and Vascular business arm in Europe.

Earlier this month, Medtronic received CE Mark for Micra AV Transcatheter Pacing System (TPS), the world’s smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired.

In the same month, the company announced the receipt of CE Mark for a one-month dual antiplatelet therapy indication for high bleeding risk patients implanted with the Resolute Onyx Drug-Eluting Stent.

In January, the company received the CE Mark for its Cobalt and Crome portfolio of implantable cardioverter-defibrillators and cardiac resynchronization therapy-defibrillators.

Price Performance

Shares of the company have lost 5.9% in the past year against the industry’s 0.2% decline.

Zacks Rank & Key Picks

Medtronic currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the same space include Quest Diagnostics Incorporated DGX, Hologic, Inc. HOLX and QIAGEN N.V. QGEN.

Quest Diagnostics’ long-term earnings growth rate is projected at 7.6%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Hologic’s long-term earnings growth rate is estimated at 7%. The company presently has a Zacks Rank #2.

QIAGEN’s long-term earnings growth rate is estimated at 12.2%. It currently sports a Zacks Rank #1.

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