Imperative Care has completed subject enrolment in the pivotal investigational device exemption (IDE) trial, SYMPHONY-PE, assessing the Symphony thrombectomy system’s efficacy and safety in treating acute pulmonary embolism (PE).
The study is designed to broaden the current usage indications of the Symphony system to include PE.
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It was carried out across 19 centres specialising in interventional radiology, cardiology and vascular surgery in the US. The investigators are planning to share the topline outcomes later this year.
Imperative Care noted that the present approved large-bore aspiration catheter system is tailored for effective thrombectomy in individuals with venous thrombosis.
The Symphony system combines large-bore power with precise vacuum in the sterile field, aiming to maximise clot removal, reducing blood loss, as well as procedural time.
It comprises three Symphony catheters, along with a controller that can be operated by the physician. The purpose-built catheters aim to enhance navigation and accurate placement.
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By GlobalDataAccording to Imperative Care, its thrombectomy system features a proximal and distal coil design to offer both trackability and flexibility.
It also includes the Imperative Care Generator, ProHelix Mechanical Assist, and various accessories.
The ProHelix Mechanical Assist is designed to engage and break down highly organised clots while reducing the need for catheter exchanges.
Acute PE is a condition that occurs due to blood clots that block the lung arteries.
Imperative Care CEO Fred Khosravi said: “Symphony is a critically important technology that is poised to transform treatment for patients with devastating pulmonary embolisms, a major cause of global morbidity and mortality. We greatly appreciate the investigators, clinical sites, and patients who have participated in this trial.”
Earlier this year, the US Food and Drug Administration (FDA) granted 510(k) clearance to Imperative Care’s Zoom System, signifying progress in stroke thrombectomy procedures.
