From New North Texas Base, Vesalio Announces U.S. Launch of Its Non-Surgical Blood Clot Removal System » Dallas Innovates

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Steve Rybka

Vesalio, a privately held medical device company focused on improving care for patients with vascular disease, has announced the launch of its pVasc Thrombectomy System in the U.S. The mechanical device is designed to nonsurgically remove peripheral emboli, or blockages in the arteries of the arms and legs caused by blood clots, inflammation and narrowing of blood vessels.

The company said the mechanical system — a self-expanding nitinol structure on a push wire — provides a “versatile, capital-neutral tool.”

pVasc targets the full range of emboli “from soft, sharp clots to fibrin-rich, calcified ones, enabling rapid and safe removal,” Vesalio added, noting that its Drop Zone technology captures, traps and safely removes the blood clot to restore flow in patients suffering from acute limb ischemia (ALI) and other conditions related to peripheral artery disease, or PAD.

“PAD is a common disease that can lead to devastating consequences,” said Vesalio CEO Steve Rybka said in a statement. “With the pVasc Thrombectomy System, physicians now have access to a critical tool to help their patients. We have received extremely encouraging early feedback on the ease of use and effectiveness of the pVasc for difficult clots. At Vesalio, we remain steadfast in our commitment to providing innovative technology to physicians treating vascular obstructions.”

Vesalio moved headquarters to Plano and hired a new CFO in May

J.D. McCulloch

In May, Vesalio announced it was moving its headquarters from Nashville, Tenn., to Plano, north of Dallas. The company — founded in 2013 — saw the Dallas area as a growing hub for Fortune 500 companies, top private companies and a cluster of medical device companies. It said its new home was chosen for its “business-friendly environment, highly educated and skilled workforce, low cost of doing business and world-class transportation infrastructure.”

That same month, Vesalio announced the hiring of J.D. McCulloch as its new CFO. McCulloch most recently served as CFO and head of business development at Dallas-based Dialectic Therapeutics, an oncology-focused biotech based in Old Parkland.

One of the doctors familiar with the use of pVasc is Dr. Frank ArkoChief of Vascular and Endovascular Surgery and Co-Director of the Aorta Institute at Carolinas Medical Center, Sanger Heart and Vascular Institute, Charlotte, North Carolina.

“Given the complex medical history of ALI patients, physicians are often challenged with delivering devices through highly diseased arteries and working in small, narrowed vessels,” Arko said in a statement. “The pVasc has a low profile and excellent deliverability, making it an especially valuable tool when access is difficult or when working in arteries below the knee.”

As many as 12 million American adults struggle with PAD

PAD affects 10 to 12 million U.S. adults ages 40 and older, Vesalio noted, increasing the risk of amputation, heart attack, stroke and death. About 185,000 amputations are performed in the U.S. each year, and more than 2 million people are currently living with an amputation. The company added that, according to the American Heart Association, nearly half of people aged 65 and older who had a limb amputated due to PAD died within a year of the procedure.

Doctor Nick Abedivascular surgeon at Fayette Surgical Associates in A doctor from Lexington, Kentucky, reported that he has achieved “very positive results with pVasc in difficult cases ranging from organized tibial artery emboli to brachial and distal ulnar artery emboli.”

“With pVasc, my patients have avoided the need for open surgery on numerous occasions, making it an invaluable tool in my practice,” he added in a statement.

Vesalio said the pVasc procedure is indicated for arteries between 2 and 6 millimeters in diameter, typically located below the knee, in the femoropopliteal arteries, mesenteric arteries, upper extremity arteries and several other locations.

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