Inquis Medical, the leading innovator in the treatment of venous thromboembolic disease, today announced the launch of SENSE-PE, an all-comer post-market registry evaluating the safety and efficacy of the AVENTUS™ Thrombectomy System in patients treated for acute pulmonary embolism (PE). Cleared by the FDA for the treatment of PE in June 2025, AVENTUS is the only thrombectomy platform combining integrated tissue-sensing technology and directional aspiration with autologous blood reinfusion to address unmet clinical needs and enhance procedural efficiency.

SENSE-PE (Surveillance and Evaluation of the AVENTUS Thrombectomy System in Real-World Pulmonary Embolism Treatment) is a prospective, multicenter, single-arm registry that will enroll up to 600 patients at up to 60 U.S. sites. The registry marks a new phase of evidence generation for the device and may inform future randomized trials.

“SENSE-PE is the first registry of this scale to evaluate real-time tissue identification together with in-line blood return,” said Ripal Gandhi, MD, a vascular interventional radiologist at Miami Cardiac & Vascular Institute and co-principal investigator of SENSE-PE. “I look forward to generating evidence on the clinical value of these technologies across hundreds of PE procedures, diverse operators, and the anatomical variability we see in everyday practice.”

The study’s primary endpoint is a composite of major adverse events within 48 hours or by discharge, whichever comes first, as judged by independent review. The composite consists of death, major bleeding, device-related clinical worsening, injury to the heart or pulmonary arteries, and the need for additional PE treatment. The registry will also measure functional and quality-of-life outcomes, as well as procedural measures such as device time and total procedure time, catheter passes through the heart, and estimated device-related blood loss.

“Most pulmonary embolism 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,” said Sameh Sayfo, MD, an interventional cardiologist at Baylor Scott & White and co-principal investigator of SENSE-PE. “A good procedural result is only part of the story. By following quality of life and six-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.”

About AVENTUS

The AVENTUS Thrombectomy System is designed to address the procedural challenges of thrombectomy, including in pulmonary embolism. By combining real-time tissue identification, directional aspiration, and in-line blood return, the platform maximizes clot-removal efficiency while minimizing blood loss and simplifying large-vessel procedures.

At the core of the system is TrueClot™ Sensing, a proprietary tissue-identification technology that provides operators with real-time feedback to differentiate between blood, clot, and vessel wall. This intra-procedural insight, combined with an atraumatic dilator tip and integrated navigation catheter, supports precision and efficiency during intervention.

AVENTUS™ is indicated for the non-surgical removal of emboli and thrombi from blood vessels, for the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel, and for autologous blood transfusion. It is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

About Inquis Medical

Inquis Medical is a medical device company focused on peripheral vascular innovations. The company is developing next-generation thrombectomy technology that is designed to give physicians greater control and precision while minimizing blood loss. Founded in 2020, Inquis Medical is led by a seasoned executive team with decades of experience bringing to market novel medical devices that address unmet clinical needs and deliver lasting impact.

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