Imperative Care has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Symphony thrombectomy system, which is designed to treat pulmonary embolism (PE).
This condition, which poses serious health risks due to blood clots obstructing lung arteries, can be addressed with the Symphony system.
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The system was previously approved for treating venous thrombosis, and this new clearance broadens its application to encompass the full range of venous thromboembolism (VTE) patient requirements.
The FDA clearance follows the completion of the SYMPHONY-PE study, an investigational device exemption (IDE) trial that assessed the efficacy and safety of the system for acute PE treatment.
It was conducted under the guidance of Mount Sinai Health System’s department of diagnostic, molecular and interventional radiology associate professor Dr Vivian Bishay and NYU Grossman School of Medicine professor Dr Sripal Bangalore.
The Symphony system features a large-bore aspiration catheter designed to enhance the efficiency of clot removal in VTE patients.
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By GlobalDataBy integrating large-capacity power with deep vacuum control, it allows healthcare professionals to remove significant amounts of clot in a reduced timeframe.
The system is equipped with 16F and 24F catheters that ensure stability and ease of navigation through complex vascular structures.
By applying a deep vacuum closer to the clot, it can achieve improved clot removal compared to traditional syringe-based and tubing-based methods.
Additionally, Symphony includes the ProHelix Mechanical Assist tool for improved clot ingestion, the Symphony 24 Advance Long Dilator for navigating challenging anatomy, and the Imperative Care Generator aspiration pump.
Imperative Care chairman and CEO Fred Khosravi said: 鈥淧ulmonary embolism can have a devastating impact on patients鈥� lives, irreversibly and within minutes.
鈥淲e remain fully committed to transforming the treatment of thrombo-embolic diseases for patients and providing physicians with technologies that make clot removal safer, easier and more effective.鈥�
