Medtronic Launches the VenaSeal Closure System in India to Treat Patients With Chronic Venous Diseases

Mumbai, Maharashtra, India:  India Medtronic Private Limited, wholly owned subsidiary of Medtronic plc (NYSE: MDT), today announced the launch of the VenaSeal™ Closure System, which is a minimally invasive procedure that uses a proprietary medical adhesive to close the diseased vein in patients with chronic venous disease (CVD) – a condition affecting more than 190 million people globally.¹

Healthy leg veins have valves that keep blood flowing to the heart. Venous reflux disease, also known as CVD, develops when the valves stop working properly and allow blood to flow backward (i.e., reflux) and pool in the lower leg veins. If CVD is left untreated, symptoms can worsen over time.

“Medtronic is committed to developing smart product and procedural solutions in the area of minimally invasive innovation to improve the quality of life for all patients,” said Madan Krishnan, vice president and managing director, India Medtronic Pvt Ltd. “VenaSeal is an innovative approach to vein closure and is designed to minimize patient discomfort and reduce recovery time.^2-5 Thousands of patients around the world have benefited from this therapy and we are pleased to now offer this advanced technology in India.”

VenaSeal uses a medical adhesive to close the diseased vein, with high closure rates across three clinical trials.^1-5Using ultrasound, the physician guides a catheter through a small access site in the leg and into the diseased area of the vein. Once in place, the physician administers the VenaSeal adhesive at various points in a segmental fashion, and with manual compression, closes the vein. Blood is re-routed through other healthy veins in the leg.

This unique approach eliminates the risk of burning or nerve injury that is sometimes associated with thermal-based procedures.⁵ The procedure is administered without the use of tumescent anesthesia (multiple injections of a dilute local anesthetic), minimizing the need for multiple needle sticks. In the VeClose trial, patients reported minimal to no pain or bruising, post procedure.⁴

About Medtronic

Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References
¹Almeida JI, Javier JJ, Mackay E, Bautista C, Proebstle™. First human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Journal of Vascular Surgery: Venous and Lymphatic Disorders 2013;1:174-180.
²Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle™. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology / Venous Forum of the Royal Society of Medicine 2014.
³ Gibson, K, and Ferris, B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study).Vascular. 2017;25(2):149-156.
⁴ Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of Vascular Surgery. 2015;61(4):985–994.
⁵ Morrison, N. Use of Cyanoacrylate adhesive for Treatment of Incompetent Great Saphenous Veins: 12-month Results of the VeClose Trial, European Venous Forum, 2015.