Medtronic's VenaSeal Closure System Positive in CVI Treatment - Analyst Blog

Medical device major Medtronic plc MDT recently unveiled 12-month results from its VeClose study, validating the clinical durability of its VenaSeal closure system, at the European Venous Forum 2015 in Russia. The trial data demonstrates the success of the VenaSeal system in closing the affected veins of 96.8% of the patients enrolled in the study, who were suffering from symptomatic venous reflux disease.

Venous reflux disease, also known as chronic venous insufficiency (CVI), occurs when the valves in the vein of one’s legs stop working properly and causes disruption in normal blood flow in the vein. Symptomatic venous reflux disease is a more advanced stage of this disease and can be fatal, if left untreated. CVI often results in varicose veins, and can lead to pain in the lower leg, swelling, skin damage and ulcerations.

Medtronic's VenaSeal Closure System is a minimally invasive treatment procedure that uses a safe-for-the-body medical adhesive to effectively close damaged veins in CVI patients. By adopting this procedure, CVI patients can avoid surgery, thermal ablation and tumescent anesthesia procedures. The risk of nerve injury associated with certain thermal-based procedures is also thereby reduced in the process.

However, treating CVI in a patient’s great saphenous vein is a tough job for physicians. In the VeClose pivotal study, Medtronic compared closure rates of damaged saphenous veins using the VenaSeal system with that of its ClosureFastcatheter thermal ablation system.

Post 3 months, the VenaSeal system successfully closed the affected great saphenous veins in 98.9% of the patients, while the ClosureFast catheter achieved a closure success rate of 95.4% of the patients. Post 6 months, the closure rate was 98.9% for the VenaSeal system, compared to 94.3% for the ClosureFast catheter. This clearly demonstrates the superiority of the VenaSeal system over the standard ClosureFast catheter approach in treatment of CVI.

With 30 million people currently afflicted with CVI in the U.S., the aforementioned study results come as a major breakthrough for Medtronic in the U.S. peripheral vascular therapies market. The fact that the VenaSeal system has won the FDA approval in Feb 2015 makes it all the more relevant. With a mere 1.9 million of affected patients having undergone treatment to date, Medtronic holds significant untapped potential in this market, going ahead.

Currently, the VenaSeal system has treatment approval in the U.S., Australia, Canada, Europe and Hong Kong. So far, more than 2,000 patients have been treated using the system.

Given the VenaSeal system's track record of clinical success, we believe the latest study results in its favor will further bolster Medtronic’s scope and existing footprint in the peripheral vascular therapies market and help it garner more profits therein.

Currently, Medtronic carries a Zacks Rank #3 (Hold). Some better-ranked medical product stocks are ZELTIQ Aesthetics, Inc. ZLTQ, NuVasive, Inc. NUVA and INSYS Therapeutics, Inc. INSY. All the three stocks sport a Zacks Rank #1 (Strong Buy).

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