FDA clears Imperative Care’s Symphony 16F 82cm catheter

Imperative Care today announced FDA 510(k) clearance of its Symphony 16 Fr 82cm catheter for venous thrombosis and announced the first successful cases.

Campbell, California-based Imperative Care said the catheter joins the Symphony Thrombectomy System’s 16 Fr 117 cm and 24 Fr 85 cm catheters.

“The customized length of the 16 Fr 82 cm catheter gives me an additional capability to address both acute and organized clot in my venous procedures,” Dr. Bennet George, an interventional cardiologist at Vital Heart & Vein in Houston who performed some of the first cases, said in a company news release.

“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 ten minutes,” George said of his experience with the new device and the Symphony system. “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.”

Imperative Care says the Symphony large-bore aspiration catheter system features “an integrated controller that delivers nearly three times the clot removal force compared to legacy aspiration systems [and] ProHelix Mechanical Assist, a unique tool designed to facilitate clot ingestion, along with the Imperative Care Generator, the most powerful aspiration pump available on the market.”

The latest catheter was purpose-built for efficient maximization of clot removal while minimizing blood loss when treating venous thrombosis, the company said.

“Thrombectomy procedures have emerged as one of the most powerful treatments in medicine, restoring vital blood flow in minutes. Historically, peripheral vascular thrombectomy has lacked technologies that effectively address challenging clot and preserve vessel health for the patient,” the company’s SVP and Vascular GM Doug Boyd said in the release. “Imperative Care set out to transform vascular care through purpose-built precision thrombectomy technologies that combine large-bore power with a precisely controlled deep vacuum within the sterile field, along with a focus on minimizing blood loss. The Symphony Thrombectomy System has introduced precision thrombectomy to the market, and we are confident it will deliver faster, safer and more precise clot removal that will ultimately benefit patients impacted by devastating vascular diseases.”

Inari Medical sued Imperative Care and its Truvic Medical subsidiary over the Symphony system in May 2024, alleging patent infringement.

Imperative Care denied wrongdoing and filed a countersuit against Inari, according to court filings. Inari, which has since been acquired by Stryker, responded by denying Imperative Care’s allegations. The case is ongoing.