Inquis Medical Launches SENSE-PE Registry of Aventus Thrombectomy System

November 2, 2026—Inquis Medical announced the launch of SENSE-PE, a postmarket registry evaluating the safety and efficacy of the company’s Aventus thrombectomy system in patients with acute pulmonary embolism (PE).

According to the company, the prospective, multicenter, single-arm registry plans to enroll up to 600 patients at up to 60 United States sites and will use an all-comer approach to assess the device in routine clinical practice.

The primary endpoint is an independently reviewed composite of major adverse events, including death, major bleeding, device-related clinical worsening, injury to the heart or pulmonary arteries, and the need for additional PE treatment, within 48 hours or hospital discharge, whichever occurs first.

Additional assessments will include functional status and quality of life (QOL), along with device time, total procedure time, the number of catheter passes through the heart, and estimated device-related blood loss. QOL and 6-minute walk distance will be assessed through 90 days.

“SENSE-PE is the first registry of this scale to evaluate real-time tissue identification together with in-line blood return,” commented Ripal Gandhi, MD, a vascular interventional radiologist with Miami Cardiac & Vascular Institute in Miami, Florida, and Coprincipal Investigator of SENSE-PE, in the company’s press release. “I look forward to generating evidence on the clinical value of these technologies across hundreds of PE procedures, diverse operators, and the anatomic variability we see in everyday practice.”

The Aventus system combines tissue sensing, directional aspiration, and autologous blood reinfusion. Its TrueClot Sensing technology provides real-time feedback to help operators distinguish blood, clot, and vessel wall, noted Inquis Medical. The platform also incorporates an atraumatic dilator tip and an integrated navigation catheter.

“Most PE studies enroll a carefully selected group of patients. SENSE-PE takes an all-comer approach, so the results will reflect the patients we actually treat every day,” added Sameh Sayfo, MD, an interventional cardiologist with Baylor Scott & White in Plano, Texas, and Coprincipal Investigator of SENSE-PE. “A good procedural result is only part of the story. By following QOL and 6-minute walk distance out to 90 days, we'll learn how patients really feel and function after thrombectomy, which is what matters most to them.”

Inquis Medical noted that the Aventus system received FDA clearance for treating PE in June 2025. The Aventus system is indicated for nonsurgical removal of emboli and thrombi; injection, infusion, or aspiration of contrast media and other fluids; and autologous blood transfusion. It is intended for use in the peripheral vasculature and for the treatment of PE.