Introducing pVasc™ mechanical thrombectomy system for the safe and effective non-surgical removal of occlusions from the peripheral vasculature

Plano, Texas – (September 4, 2024) – Vesalio announces the U.S. commercialization of pVasc™ Thrombectomy System for non-surgically removing peripheral occlusions. pVasc targets the full range of embolisms from soft, acute clots to fibrin-rich, calcified ones, enabling a fast and safe removal. Its unique Drop Zone™ technology traps, retains and securely removes thrombus to restore flow in patients suffering from acute limb ischemia (ALI) and other conditions related to peripheral artery disease (PAD).

“Given the complicated health history of patients with ALI, physicians often face the challenge of delivering devices through highly diseased arteries and working in small, stenotic vessels,” noted Dr. Frank Arko, Chief, Vascular and Endovascular Surgery and Co-Director Aortic Institute at Carolinas Medical Center, Sanger Heart and Vascular Institute, Charlotte, North Carolina. “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.”

PAD affects 10 – 12 million adults in the U.S. aged 40 and older, increasing their risk of amputation, heart attack, stroke, and death.¹ Each year, approximately 185,000 amputations are performed in the U.S., with more than 2 million people currently living with an amputation.² According to the American Heart Association, nearly half of people 65 and older who underwent a limb amputation due to PAD died within a year of surgery.³

“I have achieved highly positive results with pVasc in challenging cases that range from organized emboli in the tibials to emboli in the brachial and distal ulnar artery,” said Dr. Nick Abedi, Vascular Surgeon, Fayette Surgical Associates, Lexington, Kentucky. “pVasc has helped my patients avoid open surgery on multiple occasions, becoming an invaluable tool in my practice.”

pVasc is indicated for arteries from 2 to 6 mm in diameter, typically located below the knee, in the femoral-popliteal, the mesenteric, the upper extremities, and a few other locations. Comprised of a self-expanding nitinol structure on a pusher wire, pVasc provides a versatile tool with no need for capital equipment.

“PAD is a common disease that can lead to devastating consequences. With the pVasc Thrombectomy System, physicians now have access to a critical tool to help their patients,” stated Vesalio CEO Steve Rybka. “We received extremely encouraging early feedback on pVasc’s ease of use and efficacy in cases with challenging clots. At Vesalio, we remain steadfast in our commitment to provide innovative technologies to physicians treating vascular occlusions.”

About Vesalio

Founded in 2017, Vesalio is a privately held medical device company focused on advancing patient care in vascular diseases by providing physicians with superior technology for improving clinical outcomes. Vesalio’s proprietary NeVa™, enVast™, and pVasc™ platforms are designed to effectively remove all types of clot, leading to the rescue of compromised ischemic tissue in the brain, heart and peripheral anatomy, respectively. Vesalio’s products have treated more than 12,000 patients in over 50 countries. For more information, visit www.vesalio.com.

1. New roadmap to lower the risk of amputation in peripheral artery disease. www.heart.org. Published May 14, 2024. https://www.heart.org/en/news/2024/05/14/new-roadmap-to-lower-the-risk-of-amputation-in-peripheral-artery-disease
2. ‌Behroozian A, Beckman JA. Microvascular Disease Increases Amputation in Patients With Peripheral Artery Disease. Arteriosclerosis, Thrombosis, and Vascular Biology. 2020;40(3):534-540. doi:https://doi.org/10.1161/atvbaha.119.312859
3. Martin SS, Aday AW, Almarzooq ZI, et al. 2024 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2024;149(8). doi:https://doi.org/10.1161/cir.0000000000001209