Q’Apel Medical has been granted a CE mark under the European Medical Device Regulation (MDR) for Walrus, its balloon guide catheter (BGC) product used in the treatment of patients suffering an acute ischaemic stroke.
The Walrus BGC has been utilised by neurointerventional physicians since 2019—having gained US Food and Drug Administration (FDA) clearance in July of that year—and has successfully been used to treat more than 20,000 patients in the USA, as per a Q’Apel press release.
The Walrus BGC is a “unique development” in the field of mechanical thrombectomy procedures, the company claims, providing physicians not only with the known benefits of BGC use clinically but—uniquely to Walrus—superior ease of use in preparation for these urgent procedures.
“Importantly”, Q’Apel further claims, Walrus enables physicians to navigate the catheter into a more distal location easily and safely as compared to other systems, which is associated with improved patient outcomes from stroke.
“The anticipation of Walrus in our international markets has been enormous, and we look forward to the same performance and loyalty around Walrus we have been fortunate to experience in the USA,” said King Nelson, Q’Apel’s CEO.
“We are thrilled to be entering the EU [European Union] and other international markets with Walrus and providing more physicians in more countries the unparalleled performance of our flagship catheter,” added Jodie Fam, chief marketing officer and GM international. “This CE-mark certification represents a significant growth milestone for Q’Apel Medical, providing access to new markets.”