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FDA grants 510(k) approval for ER-Reboa catheter

Pryor Medical Devices has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its ER-Reboa catheter, allowing the firm to commercially market the product.

Resuscitative endovascular balloon occlusion of the Aorta (Reboa) is a minimally invasive technique used by the trauma, critical care and emergency medicine community to temporarily block large vessels using a balloon.

Pryor Medical Devices CEO David Spencer said: "We are proud to be the first to market with a balloon occlusion catheter designed specifically for this community.

"They asked for the unique combination of features found on the ER-REBOA catheter, and we look forward to getting it to them."

ER-Reboa features small 7 Fr size, which prevents the need for additional surgical repair at the access site.

The catheter, which doesn’t require multiple wire exchanges, has a soft and atraumatic tip that helps in simultaneous arterial pressure monitoring.

The firm plans to make the product commercially available for customers from early 2016.

Pryor Medical Devices is involved in developing and commercializing minimally invasive solutions for vascular trauma.

Currently, the company is developing multiple next generation Reboa catheters and other minimally invasive solutions.