Thrombolex Device for Mechanically Channeled Thrombolysis Evaluated in RAPID-PE

October 13, 2026—Thrombolex, Inc., announced interim results from the first 150 patients enrolled in its RAPID-PE postmarket study, a prospective, multicenter, single-arm study evaluating on-the-table mechanically channeled thrombolysis using the Thrombolex device for acute intermediate-risk pulmonary embolism (PE).

Wissam Jaber, MD, Co-National Principal Investigator of RAPID-PE, presented the findings at The VEINS 2026 conference held by the VIVA Foundation in Las Vegas, Nevada.

According to the company, no device-related deaths or ischemic or hemorrhagic strokes occurred through 30 days, and 90% of patients did not require a postprocedure intensive care unit (ICU) stay. Additional interim results included:

• All-cause mortality or hemodynamic decompensation in 0.7% of patients (1 of 150) through 7 days
• Major bleeding in 0.7% of patients (1 of 150) within 72 hours
• 100% procedural success (150 of 150) across 45 operators at 20 United States sites

“Forty-five operators at 20 sites ran the same protocol and saw the same low early event rates, and 90% of these patients needed no ICU stay,” commented Dr. Jaber in the company’s press release. “A single-session treatment with this safety profile changes the calculus of when to intervene. Most catheter-based PE treatment today happens once a patient is deteriorating. The question this data set raises is whether we should be intervening earlier, across a broader range of patients than we treat now.”

Enrollment is ongoing, with a target of 350 patients. A CTA substudy assessing the right ventricular/left ventricular ratio and subsegmental thrombus clearing is expected to be completed in 2027, noted the company. Thrombolex announced the start of RAPID-PE enrollment in October 2024. The company previously announced FDA clearance for the Thrombolex device for the treatment of acute PE in April 2023.