Cardinal Health To Gain From FDA Panel Vote For INCRAFT PMA
Zacks Investment Research | Jun 12, 2018 09:15PM ET
Cardinal Health’s (NYSE:CAH) premarket approval (PMA) application for INCRAFT (INCRAFT Stent Graft System) recently received favorable recommendation from the FDA. The Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 11 to 4 in favor of the system.
Notably, the INCRAFT system comes under Cardinal Health’s Cordis unit, which was acquired earlier in 2015. However, by the end of third-quarter fiscal 2018, the Cordis unit’s performance lacked luster. It significantly affected Cardinal Health’s earnings and effective tax rate.
Hence, the PMA for the INCRAFT system has been a timely one which will help Cardinal Health secure a broader customer base for the Cordis unit.
The INCRAFT System at a Glance
The INCRAFT system is a cardiovascular platform.
It has an advanced endovascular aneurysm repair (EVAR) technology for the treatment of infrarenal abdominal aortic aneurysms (AAAs), a severe and complex condition.
Per an article by Experimental & Clinical Cardiology, AAA rupture causes 4500 deaths each year in the United States, with an additional 1400 deaths resulting from the 45,000 repair procedures performed to prevent rupture.
Market Prospects
Per Research and Markets, the global market for cardiovascular devices reached nearly $42.4 billion in 2017 and should scale to $59.1 billion by 2022 at a CAGR of 6.9% in the 2017-2022 period.
The report further states that with medical needs of patients at an all-time high, any increase in incidences will lead to significant growth of the cardiovascular market.
Price Performance
We believe that positive developments will boost the shares of Cardinal Health, which have declined 28.5% in a year’s time, comparing unfavorably with the Original post
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