Medical device major Medtronic, Inc. (MDT) presented data from the ADVANCE Direct Aortic (DA) Study which revealed that the Core Valve System can lead to strong valve performance and positive outcomes in TAVI Patients treated via Direct Aortic Access.
This positive result is expected to boost Medtronic's position in the global TAVR market, which is expanding around 30% per the company's estimation.
The CoreValve Advance DA Study
The ADVANCE DA Study – a first-of-its-kind – was designed to evaluate the clinical utility, safety and cost-effectiveness of Medtronic's self-expanding CoreValve system for Transcatheter Aortic Valve Implantation (TAVI) in severe symptomatic aortic valve stenosis patients, who are at high risk for surgery and are not fit for undergoing the traditional transfemoral TAVI procedure. In the study, patients were implanted with the CoreValve via direct aortic approach.
The ADVANCE DA Study enrolled 100 patients and post-implantation, a one-year follow up was done on them.
The study was conducted at nine centers across Europe. The study results were presented during a late-breaking clinical session at the 29th Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS 2014) held in Milan.
Results of the Study
Results from this study revealed low rates of mortality, stroke and paravalvular leak (PVL) after 30 days of implantation. Notably, stroke rates were among the lowest reported to date for the CoreValve System, with no occurrence of disabling stroke and only one incidence of non-disabling stroke.
The study results also showed an appreciable improvement in quality of life in the CoreValve patients. Moreover, a majority of patients experienced significant improvements in heart failure symptoms post-implantation.
Financial Impact
Medtronic's CoreValve System provides the widest range of sizes to support the TAVI procedure in the maximum possible number of patients. Only last month, fresh data revealed the cost efficiency of the CoreValve system in transcatheter aortic valve replacement (TAVR) procedure.
Based on these factors, an increased number of physicians are accepting CoreValve as a suitable alternative for TAVI in high risk surgery patients. This is evident from the fact that the CoreValve System has been implanted in more than 65,000 patients in an excess of 60 countries, since it won CE (Conformité Européenne) Mark in 2007.
Per Medtronic's last reported quarter's result, barely within two months of its launch in the U.S. market, CoreValve has managed to capture 40% of the market share. We expect the positive outcomes from the ADVANCE DA Study to boost Medtronic's market share in the U.S. further in the near future, ushering in more profits at the company.
Zacks Rank
Currently, Medtronic carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical products industry include Conatus Pharmaceuticals Inc. (CNAT), ZELTIQ Aesthetics, Inc. (ZLTQ) and Abaxis, Inc. (ABAX). While Conatus Pharmaceuticals and ZELTIQ Aesthetics sport a Zacks Rank #1 (Strong Buy), Abaxis holds a Zacks Rank #2 (Buy).
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