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Medtronic: 3-Year CoreValve Data Positive in High Risk Study

Medtronic plcMDT recently unveiled new three-year clinical outcomes from the high risk study of the CoreValve U.S. Pivotal Trial, at the 65th Annual Scientific Session & Expo of the American College of Cardiology (ACC.16). 

The study results demonstrate the superiority of Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system over the standard surgical aortic valve replacement (SAVR), in high-risk aortic stenosis (AS) patients.

We believe favorable results from this trial will further enhance Medtronic’s revenues from transcatheter valves, which of late, has grown in the low-thirties, on par with the market.

Notably, AS occurs when the aortic valve in a patient’s heart narrows compared to its normal size. In such patients, a heart valve replacement is an ideal option. However, those at high risk of open surgery benefit more when implanted with a transcatheter heart valve (THV) such as Medtronic’s FDA-approved CoreValve system.

In the aforementioned high risk study, 228 patients were implanted with Medtronic’s CoreValve; while SAVR was conducted on 179. Per the outcome, all-cause mortality rate for the TAVR patient cohort was 32.9%, lower than 39.1% in the SAVR patients. Stroke rate also remained lower at 12.6% for the TAVR patient cohort as against 19% in SAVR patients.

Moreover, patients implanted with Medtronic’s CoreValve system exhibited lower rates of major adverse cardiovascular and cerebrovascular events (MACCE) compared to those who underwent SAVR – thereby demonstrating a more favorable safety profile in TAVR procedures over open heart surgeries.

In addition, Medtronic also revealed results of a sub-study analysis of the high risk study involving AS patients with an STS Predicted Risk of Mortality estimate of less than 7%. Notably, an STS score is used to determine whether patients with severe AS should undergo SAVR or TAVR.

The results from this sub-study demonstrated the superior survival benefit that CoreValve patients with lower STS mortality risk scores achieved over surgery patients; post a two-year follow up. In this sub-study, patients implanted with CoreValve also witnessed significantly better valve hemodynamics as well as improved quality of life compared to those who underwent surgery.

We note that the TAVR procedure has lately emerged as a convenient and popular treatment option for severe AS patients who are practically inoperable. It is estimated that by 2050, 17% of the global population will be over the age of 65, thereby increasing the patient pool, that is people who are more prone to fall prey to AS.

An increased number of physicians are gradually adopting Medtronic’s CoreValve portfolio as a suitable alternative for TAVR in high-risk surgery patients. Evidently, the CoreValve System has been implanted in more than 100,000 patients across over 60 countries, ever since it won CE Mark in 2007.

At present, the global TAVR market is expected to reach a value worth $4 billion by 2020. Given this backdrop, we believe the aforementioned study results in favor of Medtronic’s CoreValve system will allow the company to capture a larger share of the global market potential.

Meanwhile, heart valve pioneer Edwards Lifesciences Corp. EW has also released favorable PARTNER II study results at the same time as Medtronic’s aforementioned data. The PARTNER II trial clinical outcomes demonstrate the superiority of Edwards’ Sapien family of valves over open-heart surgery in intermediate risk AS patients. We believe the simultaneous news release from its biggest peer in the TAVR market will pose competitive challenges for Medtronic, going ahead.

Zacks Rank & Other Stocks

Medtronic currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical sector are LeMaitre Vascular, Inc. LMAT and Orthofix International N.V. OFIX. Both the stocks sport a Zacks Rank #1 (Strong Buy).

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