Thrombolex Bashir Catheters Evaluated in RESCUE Trial for Treating Acute Intermediate-Risk PE

January 17, 2022—Thrombolex, Inc. announced positive results from the prespecified interim analysis of the first 62 evaluable pulmonary embolism (PE) patients enrolled in the pivotal RESCUE trial, which is being conducted under an FDA investigational device exemption (IDE).

Trial investigator Ripal Gandhi, MD, of the Miami Cardiac and Vascular Institute in Miami, Florida, presented the data during the Late Breaking Clinical Trials session at ISET 2022, the International Symposium on Endovascular Therapy held January 16-19 in Hollywood, Florida.

Thrombolex stated that RESCUE is a prospective multicenter, single-arm pivotal trial evaluating the efficacy and safety of the company’s Bashir and Bashir S-B endovascular catheters in the treatment of acute intermediate-risk PE. The trial is scheduled to enroll at least 100 evaluable patients.

The Bashir devices have received FDA 510(k) clearance for the localized infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The goal of the RESCUE IDE study is to achieve an additional indication for use of these devices in the treatment of acute PE, advised Thrombolex.

During the ISET session, Dr. Gandhi reported new detailed data on the reduction of clot burden in segmental pulmonary arteries.

According to Thrombolex, the data demonstrated a 90% reduction in the number of totally occluded segmental pulmonary arteries (P < .0001) and a 72% reduction in subtotal and total occlusions of segmental arteries (P < .0001) at 48 hours postprocedure compared to baseline by CT angiogram. Each of the 20 segmental arteries showed a reduction in the degree of obstruction

The trial met its primary endpoint for reduction in right heart strain. At 72 hours postprocedure there were no major bleeds, no major adverse events, and a zero-mortality rate. Collectively these patients experienced substantial improvement in hemodynamics and symptoms, which translated to improvements in right heart strain, cardiac function, and functional status. These initial data have not been reported in any of the previous clinical trials of acute PE, noted the company.

“These interim results from the RESCUE trial are very exciting,” commented Dr. Gandhi in the Thrombolex press release. “The reduction in thrombus burden at 48 hours after treatment, as assessed by the independent core lab, is remarkable especially with no bleeding complications. Complete resolution of thrombus burden should be an important goal of treatment.”

Dr. Gandhi concluded, “This represents a promising novel technology for the treatment of acute pulmonary embolism and other forms of large vessel venous thromboembolic disease.”