Imperative Care today announced Food and Drug Administration (FDA) 510(k) clearance of the 82cm version of its Symphony 16F catheter, the company’s latest innovation designed to elevate care for patients with venous thrombosis.
The company also announced the successful completion of initial patient cases using the catheter. Several of these were completed by Bennet George, MD, an 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. 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,” said George. “The customized length of the 16Fr 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.”
This latest innovation expands the Symphony thrombectomy system offering to include 16F 82cm, 16F 117cm and 24F 85cm catheters.
Imperative Care details that Symphony has an integrated controller that delivers nearly three times the clot removal force compared to legacy aspiration systems. Additionally, the system includes the ProHelix Mechanical Assist, a tool designed to facilitate clot ingestion, along with the Imperative Care Generator, an aspiration pump.
