Medical device manufacturer, St. Jude Medical, Inc. STJ, recently received a go-ahead from the FDA to resume the U.S. IDE trial for the evaluation of Portico Transcatheter Aortic Valve Implantation System. The trial had originally been launched in May 2014.
In Sep 2014, St. Jude temporarily halted worldwide implants of the valve amid reports of reduced leaflet motion observations in patients implanted under the scope of the study. The observation was later observed in the study’s control arm, which comprised commercially available Transcatheter Aortic Valve Replacement (TAVR) valves.
The FDA conducted an extensive review of the Portico system and, satisfied by its findings, finally gave the green signal for the resumption of the trial. The Portico system was primarily designed to simplify the TAVR procedure, which is ideal for patients not fit for open-heart surgery.
The Portico system usually comes with better control and improved accuracy, as compared with other TAVR valves available in the market. The system is also designed to provide optimal placement in patients.
We believe this is an important development for St. Jude. The company can now successfully resume its evaluation trial in the U.S. and move closer to its targeted launch of the product. The valve has already received positive reviews from clinical trials in Europe and other geographies.
TAVR is a relatively new technology in the field of medical science. It is a minimally invasive procedure undertaken to replace a narrowed aortic valve that fails to open properly (aortic stenosis). A rise in the ageing population and higher prevalence of inoperable aortic stenosis are expected to drive significant market growth for this product, going forward.
While North America dominates the global market, the heart valve repair and replacement market in Asia Pacific is expected to show high growth rates in the upcoming years. We feel St. Jude is poised to gain significant market share in these markets, upon successful evaluation of its Portico valve.
Stocks to Consider
Currently, St. Jude has a Zacks Rank #3 (Hold). Better-ranked medical stocks at the current moment include AMN Healthcare Services AHS, Cancer Genetics CGIX and INC Research Holdings INCR. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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