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Devices Interventional FDA

 News Release - October 7, 2021

Venclose MAVEN Earns FDA Clearance to Treat Incompetent Perforator Veins

Next-generation radiofrequency catheter offers first thermal ablation perforator treatment advancement in over 10 years

SAN JOSE, Calif., Oct. 7, 2021 -- (Healthcare Sales & Marketing Network) -- Venclose Inc., a privately-held Silicon Valley medical device company focused on innovative treatment procedures for venous reflux disease today announced FDA 510(k) clearance for Venclose Maven™, a novel radiofrequency ablation (RFA) catheter for minimally invasive treatment of incompetent perforator veins (IPVs). The Venclose Maven catheter represents Venclose's commitment to developing next-generation venous treatment solutions that help physicians provide more comprehensive patient care.

"While our existing Venclose® RF Ablation System, including the proprietary Venclose Catheter, continues to displace older technology for treating incompetent truncal veins, Venclose Maven will now allow doctors to also address refluxing perforators, a separate category of veins that contributes to more advanced and serious venous disease symptoms including painful venous stasis leg ulcers," said Jerry Gibson, Venclose Chairman and CEO.

Like Venclose's flagship catheter, the Venclose Maven is engineered to facilitate vein wall contact via both segmental and circumferential thermal delivery. These performance features were applied with the knowledge that physicians already familiar with this ablation method could quickly and easily incorporate the Venclose Maven catheter into their practices for IPV treatment.

According to Jeff Carr MD, FACC, board-certified Interventional Cardiologist with CardiaStream of Tyler, TX, "The Venclose Maven Catheter is uniquely designed to expand our options for treating IPVs and associated tributaries. With the 0.5cm length treatment coil and 20 second treatment cycles, I have more confidence in applying a uniform therapeutic effect to the vein. This is a significant improvement over the existing RF device for IPVs." Dr. Carr also spoke to the procedural ease of use by adding, "Delivering treatment is super simple and efficient due to the flexibility, lubricity and low profile of the device."

Board-certified vascular and interventional radiology physician Carlos Hamilton III, MD of Hamilton Vascular, Sugarland, TX similarly experienced the procedural advantage of the Venclose Maven Catheter compared to the decade-old legacy method. "It's a lot smoother procedure with reduced in-vein treatment time." Dr Hamilton added, "The Venclose Maven is a lot easier to work with and seems much better tolerated by my patients. And the higher temperature allows for a much faster procedure."

In addressing Venclose's business outlook, Mr. Gibson stated, "We are very pleased that for the benefit of Venclose stakeholders, the FDA's rapid 510(k) clearance of the Venclose Maven now allows the company to pursue a 15% growth opportunity in the U.S. Market where it had previously been unable to compete. We intend to also grow the market by helping clinicians who are presently not treating IPVs to expand their patient care services."

Venclose is shipping the Maven catheter to U.S. vein practices as it pursues CE Mark approval for delivery to its expanding EU markets.

The Venclose System

The Venclose System is the next-generation, best-in-class endovenous RF ablation system designed to close the damaged vein and restore healthy blood flow in patients with venous reflux disease, a progressive medical condition which is often associated with varicose veins.

About Venclose, Inc.

Venclose is a privately held, commercial-stage Silicon Valley medical technology company developing next-generation solutions for the treatment of venous reflux disease, also known as chronic venous insufficiency (CVI). CVI is a progressive medical condition affecting more than 40 million adults in the United States alone. The VENCLOSE RF Ablation System offers physicians more versatility than earlier generation endovenous radiofrequency ablation technologies and is commercially available in the United States and Europe. For more information, visit www.venclose.com.


Source: Venclose

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