Thrombolex Begins Enrollment in RAPID-PE Postmarket Study of Bashir Catheter

October 23, 2024—Thrombolex, Inc. announced the commencement of enrollment in the RAPID-PE study, which uses the company’s Bashir endovascular catheter for treatment of acute pulmonary embolism (PE).

According to the company, the single-arm, multicenter postmarket study is evaluating the safety and effectiveness of on-table pharmacomechanical lysis (PML) without postprocedural thrombolytic infusion using the new 0.035-inch, guidewire-compatible Bashir device.

Thrombolex stated that its next-generation platform technology is engineered for optimal resolution of thrombus in the treatment of PE. Patients with acute intermediate-risk PE are treated with four 1 mg pulse sprays of recombinant tissue plasminogen activator (r-tPA) into each pulmonary artery without subsequent r-tPA infusion.

The first two patients in the study were enrolled by interventional cardiologist Ayman Iskander, MD, at St. Joseph’s Health Hospital in Syracuse, New York. The patients were discharged from the hospital in good health less than 24 hours postprocedure, noted the company.

“It was exciting to see a dramatic improvement in hemodynamics on the table in both patients with very short treatment times (one bilateral, 38 minutes and one unilateral, 16 minutes) in the cath lab,” commented Dr. Iskander in the Thrombolex press release. “This approach may eliminate the need for an intensive care unit stay, which could be a boon to the overburdened health systems.”

Wissam Jaber, MD, Professor of Medicine and Director of the Cath Lab at Emory University in Atlanta, Georgia, is Conational Principal Investigator of the RAPID-PE study.

“We are pleased to see the enrollment of the first two patients in the RAPID-PE study and are very encouraged by the clinical response with this novel PML approach,” stated Dr. Jabber in the press release. “We believe this protocol will be as effective as traditional PE therapies and potentially safer, due to the ultra-low dose of lytics used. This is a logical next step in improving upon the excellent clinical results from the original RESCUE study.”

Thrombolex noted that the RESCUE study, which enrolled 109 patients with intermediate-risk PE at 18 hospitals in the United States, showed the device’s effectiveness and safety in this patient population.

Data from RESCUE-II, a related single-center study from Temple University Hospital in Philadelphia, Pennsylvania, that used the on-table protocol will be presented on October 28 at TCT 2024, the Transcatheter Cardiovascular Therapeutics conference held October 27-30 in Washington, DC, advised the company.