New Length of Imperative Care’s Symphony Catheter Cleared by FDA

March 24, 2025—Imperative Care, Inc. announced FDA 510(k) clearance of the 82 cm version of its Symphony 16-F catheter for the treatment of venous thrombosis.

The company also announced the successful completion of initial patient cases using the Symphony 16-F, 82-cm catheter.

Bennet George, MD, an interventional cardiologist at Vital Heart & Vein in Houston, Texas, performed several of the initial procedures with the device.

“In my early experience, I’ve been able to consistently achieve 97% clot removal in, on average, two passes, with minimal blood loss (< 120 ml) in less than 10 minutes,” commented Dr. George in the company’s press release. “With a large-bore catheter and powerful deep vacuum, Symphony allows me to effectively treat highly challenging clot morphologies in minutes and in a blood-efficient way, ensuring the best possible outcomes for my patients.”

Dr. George added, “The customized length of the 16-F, 82-cm catheter gives me an additional capability to address both acute and organized clot in my venous procedures, and I look forward to its continued impact on the patients we treat.”

According to Imperative Care, the Symphony thrombectomy system includes an integrated controller that delivers clot removal force; the ProHelix mechanical assist tool to facilitate clot ingestion; and the Imperative Care Generator, an aspiration pump.

This latest clearance expands the Symphony thrombectomy system portfolio to include the 16-F, 82-cm; 16-F, 117-cm; and 24-F, 85-cm catheters, stated the company.