The U.S. Food and Drug Administration (FDA) has recently cleared Medtronic plc's (MDT) VenaSeal closure system for use in the treatment of patients in the U.S., who suffer from venous reflux disease, also known as chronic venous insufficiency (CVI).
Notably, earlier in 2014, Covidien plc had taken over VenaSeal's original developer, North Carolina-based Sapheon Inc. The Jan 2015 acquisition of Covidien by Medtronic saw VenaSeal coming under the wings of the latter.
CVI is a medical condition that results in disruption in proper blood flow through the veins and vessels in the legs. CVI is often preceded by varicose veins, which occur when the valves in the veins of the lower limb fail to function properly, causing blood to pool in the legs. If left untreated, CVI can significantly impact one's quality of life over the long term.
Medtronic's VenaSeal Closure System is a unique, minimally invasive treatment procedure that uses a safe-for-the-body medical adhesive to quickly and effectively close damaged veins in patients with CVI.
This treatment option, being a non-thermal one, eliminates the risk of nerve injury that is sometimes associated with certain thermal-based procedures. Moreover, unlike other procedures, the VenaSeal system can be used without applying anesthesia to the patients. This allows a speedy return to normal life post-treatment.
Currently, this system has treatment approval in the markets of U.S., Australia, Canada, Europe and Hong Kong. So far, more than 2,000 patients have been treated with the VenaSeal system.
To date, three trials have been conducted to validate the clinical safety and efficacy of the VenaSeal procedure. Evidently, in the first human trial, the closure rates were 92% at both 12 and 24 months respectively.
A cumulative closure rate of 92.9% at 12 months was demonstrated by the European Sapheon Closure System Observational ProspectivE (eSCOPE) study. Moreover, the recently released three-month VeClose pivotal trial delivered an excellent closure rate of 98.9% for the VenaSeal procedure.
CVI is a rather common medical condition. As per recently found data (rethinkvaricoseveins.com), more than 30 million U.S. citizens are affected by CVI. However, most of the cases remain unaddressed; only 1.9 million of affected patients undergo treatment.
Given the VenaSeal system's track record of clinical success, we believe, Medtronic will be able to expand its customer base and garner more profits by catering to the large number of under-treated CVI patients. We expect the system to gain momentum at Medtronic once the company launches it in the U.S. as expected this spring.
Zacks Rank
Currently, Medtronic holds a Zacks Rank #2 (Buy). Some other medical product stocks worth considering over the short term are Abaxis, Inc. (ABAX), Vascular Solutions Inc. (VASC) and Phibro Animal Health Corp. (PAHC). All three stocks sport a Zacks Rank #1 (Strong Buy).
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