FDA OKs Imperative Care’s Symphony 16F 82cm Catheter

Imperative Care has earned U.S. Food and Drug Administration (FDA)510(k) clearance for the 82cm version of its Symphony 16F catheter for venous thrombosis.

Venous thrombosis is a serious condition caused by a blood clot’s formation in the veins of the legs or abdomen. If left untreated, the clot can have a life-threatening impact.

The company also successfully completed the first patient cases using the Symphony 16F 82cm catheter. Several of those cases were completed by Dr. Bennet George, Interventional Cardiologist at Vital Heart & Vein in Houston, Texas.

“In my early experience, I’ve been able to consistently achieve 97% clot removal in, on average, two passes, with minimal blood loss (<120ml) in less than ten minutes,” said Dr. George. “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. The customized length of the 16F 82cm 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.”

The Symphony thrombectomy system now includes 16F 82cm, 16F 117cm and 24F 85cm catheters. The large-bore aspiration system combines large-bore power with precise deep vacuum in the sterile field.

According to Imperative Care data on file, Symphony’s integrated controller delivers almost three times the clot removal force of legacy aspiration systems. The system also features ProHelix mechanical assist, a tool to facilitate clot ingestion, and the Imperative Care Generator, a powerful aspiration pump.

“At Imperative Care, we have always started by looking at critical unmet needs across the patient journey and working with a connected-care mindset to purposefully engineer solutions that put patients in the best position to live full and independent lives,” said Fred Khosravi, chairman and CEO of Imperative Care. “With this latest offering and the enabling innovations in development at Imperative Care, we are poised to further advance the paradigm of care and provide physicians with the technologies that allow them to swiftly address these urgent ischemic diseases and best care for their patients.”

Earlier this year, the company won FDA clearance for its Zoom system, a comprehensive stroke thrombectomy system that includes the first large-bore .088” catheters indicated for both access and aspiration.