The latest data from Medtronic ($MDT) demonstrate just how wide its market reach extends. It found that a recently approved adhesive treatment for chronic venous insufficiency is comparable to radiofrequency ablation via a device that it also markets. That makes it seem like a win-win for the medical device giant, which now offers two equivalent, but distinct, treatment modalities.
The former, the VenaSeal Closure System, was acquired by Covidien for an undisclosed sum in August 2014 with the purchase of Sapheon. The latter is Covidien's ClosureFast endovenous radiofrequency ablation catheter. Medtronic gained both when it acquired Covidien for about $50 billion in January.
|Using ultrasound to guide the VenaSeal catheter through a vein--Screenshot courtesy of Covidien|
VenaSeal was approved by the FDA in February to treat chronic venous insufficiency (CVI), which occurs when the valves in the veins of the lower leg aren't working properly and allow blood to flow backward. This can result in enlarged, or varicose veins, and can lead to lower leg pain, swelling, skin damage and ulcerations.
But unlike other treatments, the medical adhesive doesn't require tumescent anesthesia and allows patients to immediately return to normal activity after the procedure. In addition, it eliminates the risk of heat-related injury that is associated with thermal-based procedures and may reduce the need for the use of compression stockings after the procedure.
"The VenaSeal closure system provides patients with a minimally invasive procedure that eliminates the need for surgery, thermal ablation and tumescent anesthesia. As a result, patients are often able to quickly return to normal activities after the procedure," Dr. Nick Morrison, the national principal investigator for the VeClose study. "The results show sustained closure with VenaSeal closure system that is comparable to closure rates with radiofrequency at 12 months."
The study found that after 12 months VenaSeal and the ClosureFast treatment arms had identical great saphenous vein closure rate of 96.8% with no serious adverse events reported, the company said. The study had 222 patients with 108 randomized to the VenaSeal arm and 114 to the ClosureFast arm.
To use VenaSeal, a physician guides a tiny catheter via ultrasound through a small access site in the skin to the diseased portion of the vein. Next a small amount of the cyanoacrylate glue is dispensed to close the vein, which immediately re-routes blood flow to healthy veins. In addition to the U.S., it's approved for use in Australia, New Zealand, Canada, Europe and Hong Kong; VenaSeal has been used to treat more than 2,000 patients.
"The 12-month results of the VeClose trial demonstrate the durability of the system," Dr. Mark Turco, the medical director of the Aortic and Peripheral Vascular business at Medtronic said in a statement. "This, combined with the improved patient comfort and reduced recovery times of the VenaSeal closure system, makes this a clinically-proven, patient-friendly treatment option for patients."
- here is the release