Medtronic plcMDT recently announced the commencement of a new real-world study - the Evolut R Forward Clinical trial - subsequent to reporting patients' enrollment in this multi-center, single-arm study. This prospective post-market study aims at evaluating the clinical and device-related performance outcomes of Medtronic's CoreValve Evolut R System in treating aortic stenosis (AS) patients, in routine clinical practice.
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 is a medical condition that 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) like Medtronic's Evolut R - a next-generation, recapturable and repositionable transcatheter aortic valve implantation (TAVI) system.
The first set of patients in the Forward Study was enrolled in the University Hospital in Bonn, Germany. Medtronic plans to enroll up to 1,000 high- and extreme-risk patients in at least 60 centers across the globe.
The primary endpoint of the Forward Study will evaluate all-cause mortality rates at 30 days post-implant of Evolut R in severe symptomatic AS patients. Secondary endpoints will estimate the device's success and efficacy according to VARC-2.
A quick review of the CoreValve Evolut R System's past performance reveals the promising clinical results that this TAVI valve has demonstrated compared to its peers in its pre-market trial. Evidently, data from the recently presented Evolut R CE Study demonstrated the highest reported survival rate of 93.3% for high and extreme risk AS patients at 1-year follow-up.
Data from this study, presented at the latest Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, also reported a low 1-year stroke rate at 3.4%, strong hemodynamic performance, low rates of moderate or severe paravalvular leak of 4.3% at 1-year, and low pacemaker implantation rate of 15.2% at 1-year.
Built on the proven foundation and procedural success of the CoreValve System, which has been implanted in more than 100,000 patients in 60 countries, we expect the CoreValve Evolut R to demonstrate similar outstanding performance in the Forward study as well. This in turn will increase the adoption of the Evolut R, across the globe and in turn, improve the company's Cardiac and vascular group's revenues.
In fact, the commencement of the Forward Evolut R trial comes only a couple of weeks after the company won the FDA approval for undergoing an investigational device exemption (IDE) trial for the device, which will enroll 1,200 severe AS patients, who are at low surgical mortality risk of less than 3%.
In recent times, the TAVR procedure has emerged as a convenient and popular treatment option for severe AS patients who are practically inoperable. It is estimated that by 2030, 20% of the U.S. population will be over the age of 65. More prone to fall prey to AS, this section of the population will increase the potential patient pool for Medtronic.
With the global TAVR market currently expected to be worth $4 billion by 2020, we believe the consequent release of these news will allow Medtronic to capture a larger share in this space, going ahead.
Currently, Medtronic has a Zacks Rank #3 (Hold). Some better-ranked medical product stocks are Hill-Rom Holdings, Inc. HRC , OraSure Technologies, Inc. OSUR and Vascular Solutions Inc. VASC . All the three stocks sport a Zacks Rank #1 (Strong Buy).