Medtronic introduces VenaSeal closure system in the US

9 November 2015 (Last Updated November 22nd, 2018 11:20)

Ireland-based medical technology company Medtronic has launched the VenaSeal closure system in the US, which was developed to treat symptomatic venous reflux.

Veclose

Ireland-based medical technology company Medtronic has launched the VenaSeal closure system in the US, which was developed to treat symptomatic venous reflux.

It is the first and only non-tumescent, non-thermal, non-sclerosant procedure approved for the treatment of this disease.

The VenaSeal closure system also received pre-market approval (PMA) from US Food and Drug Administration (FDA) for this treatment.

VenaSeal is a minimally invasive procedure, which uses a medical adhesive to close superficial veins of the lower extremities such as the great saphenous vein, in patients with symptomatic venous reflux.

Lake Washington Vascular physician Kathleen Gibson performed the first treatment of a US patient with the VenaSeal closure system.

Gibson said: "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.

"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."

"The VenaSeal procedure is shown to be safe and effective, with consistent results across three clinical trials."

Venous insufficiency occurs when valves in the veins of the leg no longer function properly, which allows blood to flow backward, or reflux, resulting in enlarged or varicose veins that become painful and can limit quality of life.

The physician uses an ultrasound to directs a catheter through a small access site in the leg and into the diseased area of the vein.

Once in place, the physician distributes 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.

The company noted the approach reduces the risk of burning or nerve injury that is sometimes associated with thermal-based procedures, and is administered without the use of tumescent anesthesia.

The company noted in the VeClose trial, patients reported minimal to no pain or bruising post-procedure.

VeClose trial national principal investigator Dr Nick Morrison said: "The VenaSeal procedure is shown to be safe and effective, with consistent results across three clinical trials.

"One year results of the VeClose pivotal study that led to the approval of VenaSeal closure system in the US, continue to demonstrate safety and efficacy of the procedure, with closure rates of 97.2%."

Currently, the VenaSeal system is available in New Zealand, Chile, South Africa, Australia, Canada, Europe, the UAE and Hong Kong, in addition to the US.

In October, the company introduced a new version of its superDimension navigation system software, which offers a minimally invasive approach to evaluate difficult-to-reach areas of the lung, allowing diagnosis of lung diseases.

By using the patient's CT scan, superDimension planning software generates a 3D virtual bronchial tree, which helps physicians to map pathways to reach pulmonary targets during the electromagnetic navigation bronchoscopy (ENB) procedure.


Image: Medtronic's VenaSeal closure system. Photo: courtesy of Medtronic.