The Food and Drug Administration (FDA) has granted 510(k) clearance for Vesalio’s enVast clot retriever, paving the way for its commercial launch in the US.
The device is said to be the first clot retriever cleared for mechanical thrombectomy in the cardiac circulation.
Related: Nephrodite’s continuous dialysis implant wins FDA breakthrough device designation
It brings a new approach to capture and remove clots, addressing the needs of those with a large thrombus burden (LTB), a frequent and complex issue encountered during primary percutaneous coronary intervention (PCI).
Effective and timely restoration of coronary blood flow is essential in these cases to limit myocardial damage and decrease complications.
Leveraging the company’s Drop Zone technology, enVast is engineered to engage and remove a wide range of coronary thrombi, including both soft, easily fragmented clots and those rich in fibrin that are said to be often resistant to current retrieval or aspiration methods.
Drop Zone technology is said to capture the thrombus within the device while the closed distal tip prevents it from escaping during removal.
The device aims to enable quick clot extraction and restore blood flow to ischemic myocardium. It also secured regulatory clearance in Europe.
After clinical adoption of the device in key international markets, the clearance expands the company’s portfolio in the US to include solutions for vascular occlusions.
Vesalio CEO Steve Rybka said: “With FDA clearance and the upcoming US launch of enVast, we are proud to introduce a device that we truly believe redefines coronary thrombectomy.
“enVast is the first coronary-specific retriever designed with a stent-based clot capture architecture enhanced by our proprietary Drop Zone technology. Clinical experience internationally has consistently demonstrated its safety and effectiveness in managing complex LTB situations. We’re excited to now make this impactful solution available to US interventional cardiologists and their patients.”
Established in 2017, Vesalio specialises in technologies for treating thromboembolic vascular disease.
