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Medtronic announced the U.S. launch of the VenaSeal closure system. This system is the first and only non-tumescent, non-thermal, non-sclerosant procedure approved by the FDA for the treatment of symptomatic venous reflux in the United States. The VenaSeal is a minimally invasive procedure that uses a proprietary medical adhesive to close superficial veins of the lower extremities.
Venous insufficiency occurs when valves in the veins of the leg no longer function properly. This disease allows blood to flow backward, or reflux, resulting in enlarged, or varicose veins that become painful and can limit quality of life. Venous insufficiency affects more than 30 million Americans and is common in women who have had two or more pregnancies.
“Medtronic today furthers our commitment to providing treatment options for patients with symptomatic venous reflux, a disease that can significantly impact quality of life,” said Sandra Lesenfants, vice president and general manager of the endoVenous business in Medtronic’s Aortic and Peripheral Vascular division. “Thousands of patients have benefited from this procedure around the world, and we are pleased to now offer this advanced technology as an option to our U.S. physicians and patients.”
In the procedure, an ultrasound-guided catheter is inserted through a small access site in the leg and directed into the diseased area of the vein. Once in place, the physician administers the VenaSeal adhesive at various points in a segmental fashion, closing the vein with manual compression. Blood is rerouted through other healthy veins in the leg.
“Patients are often told their varicose veins are only a cosmetic issue, but varicose veins are a sign of a condition known as venous insufficiency, which can cause symptoms that impact quality of life, and over time can lead to more serious problems,” explained Kathleen Gibson, M.D., Lake Washington Vascular, Seattle, who performed the first treatment of a U.S. patient on October 21, 2015 with the VenaSeal closure system since approval. “Left untreated the venous insufficiency often progresses, and can cause leg pain, leg and ankle swelling, leg heaviness and fatigue, skin changes or rashes, ulcers and open wounds.”
This approach aims to eliminate the risk of burning or nerve injury that is sometimes associated with thermal-based procedures. The procedure is administered without the use of tumescent anesthesia, minimizing the need for multiple needle sticks. In the VeClose trial, patients reported minimal to no pain or bruising after the procedure, advised 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 85,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
For Further Information
More on the markets for peripheral vascular devices in the US can be found in the latest report suite published by iData entitled US Peripheral Vascular Device Market – 2016, which covers the US as well as the following sub-segments: peripheral vascular stents, PTA balloon catheters, atherectomy devices, chronic total occlusion devices, embolic protection devices, stent-grafts, surgical grafts, AV access thrombectomy devices, inferior vena cava filters, diagnostic and interventional catheters, standard and hydrophilic guidewires, introducer sheaths, vascular closure devices, and transcatheter embolization devices.
The iData series on the market for peripheral vascular devices also covers China, India, Japan, and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.
About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by state, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.
About Reimbursement Tracker
iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.
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