New Britain, PA, January 23, 2024 — Thrombolex, Inc. announced the enrollment of the first patient in the RESCUE II study using the BASHIR™ Endovascular Catheter for the treatment of acute intermediate-risk pulmonary embolism by Drs. Riyaz Bashir and Vladimir Lakhter, at Temple University Hospital, Philadelphia, Pennsylvania. The RESCUE II study evaluates the efficacy of on-table pharmacomechanical lysis (PML) without post-procedural thrombolytic infusion using the new 0.035” guidewire compatible BASHIR™ Endovascular Catheter. Patients with acute intermediate-risk pulmonary embolism (PE) are treated with four 1 mg pulse sprays of rt-PA into each lung without subsequent rt-PA infusion, which generally requires admission to an intensive care unit.

Dr. Parth Rali, the PI of the RESCUE II study and Associate Professor of Thoracic Medicine and Surgery at Lewis Katz School of Medicine at Temple University commented, “It was exciting to see a dramatic on-table hemodynamic improvement in a patient with a low cardiac index using the RESCUE II protocol. This approach may eliminate the need for an ICU stay, which would be a boon to the overburdened health systems and open the technology to a much wider array of hospitals, including those that do not have intensive care units.” Dr. Riyaz Bashir, Professor of Medicine at the Lewis Katz School of Medicine at Temple University, commented, “We are pleased to enroll the first patient in the RESCUE II study and are very encouraged by the clinical and hemodynamic response with this novel PML approach. This logical next step in advancing this therapy could be another significant milestone following the recently published RESCUE trial.” The RESCUE trial enrolled 109 patients with intermediate-risk PE at 18 US hospitals. It showed unsurpassed efficacy and safety in this patient population compared to recently published studies with other FDA-cleared devices.