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InVera Medical has received FDA 510(k) clearance for the InVera Infusion Device, a new minimally invasive device designed to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins.
According to the company press release, Chronic Venous Disease (CVD) affects one in four adults and can progress from visible varicose veins to painful leg ulcers, if left untreated. It affects over 120 million people across the US and Europe with only about 1% of those living with venous disease currently receiving treatment each year. InVera is designed to help reduce the gap in treatment with its alternative to thermal burning technologies and current non-thermal methods.
The InVera Infusion Device features a 5Fr catheter with a novel helical coil to mechanically prepare the vein wall by disrupting the inner media layer for enhanced infusion of sclerotherapy agents. This minimally invasive procedure offers significant improvements in procedural efficiency for physicians, requiring only a single injection of local anesthetic, which supports faster patient recovery.
InVera’s Infusion Device, the company says, offers a more comfortable, effective, non-thermal and non-implant alternative for CVD patients. “There is a clear clinical need for a non-thermal procedure that is both less invasive and highly effective for CVD. Existing thermal options involve many painful injections, risk skin and nerve injury, and often lead to significant bruising, swelling and prolonged recovery periods for patients making them poorly suited to the Office Based Lab (OBL) setting. Current non-thermal methods can be ineffective, painful, or burdened by the risk of permanent glue implantation. The InVera Infusion Device provides a safer, less invasive and effective alternative that can benefit millions of patients.” said Nigel Phelan, Chief Medical Officer and Co-Founder of InVera Medical.
“FDA 510(k) clearance and CE Mark approval are major milestones for InVera Medical, enabling our limited market release in select US and European centers this year. With dual approvals and promising 12-month pilot data demonstrating strong safety and procedural outcomes, we are excited to offer CVD patients and physicians a less invasive and highly effective option. Our technology aims to expand the fastest growing non-thermal segment of the superficial venous reflux market which sees over 1 million annual procedures in the US alone.” said Stephen Cox, CEO and Co-Founder of InVera Medical.
The InVera Infusion Device is approved for use in the US and EU within its indications.
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