Phenox Receives CE Mark for Thrombectomy Device

Phenox GmbH has been granted CE mark approval for its pREset Lite Thrombectomy device, a product that gives physicians new options for the intracranial treatment of ischemic stroke.

“The pREset Lite has been developed to enable physicians treating ischemic stroke even in the very distal and therefore very sensitive area of the brain,” said Hermann Monstadt, managing director at Phenox. “It is based on the design of the pREset thrombectomy device which has proven its clinical effectiveness in many hundred cases.”

With the new pREset Lite, the pREset, BONnet and BONnet short devices, Phenox GmbH now offers a broad range of thrombectomy devices for the treatment of ischemic stroke.

“Stent retrievers have been revolutionizing acute stroke treatment. The latest innovation on this field is the pREset Lite, a 3- and 4-mm stent retriever that navigates through a 10-microcatheter,” said Vitor Mendes Pereira, M.D., head of Interventional Neuroradiology at the University Hospital of Geneva, Switzerland. “It significantly improves the access to distal lesions, improves aspiration capabilities from proximal balloon guiding catheter or distal access catheters while keeping the same effectiveness on retrieving the thrombus from the occluded vessel.”

Like the phenox pREset thrombectomy device the pREset Lite has a proximal closed “ring” design, ensuring a stable opening, reducing tapering when withdrawn and providing optimized distribution of radial force, the company noted in a news release. Together with its helically shaped slit the pREset Lite facilitates the safe and effective treatment of ischemic stroke, phenox claims. The pREset Lite is available in two sizes with diameters of 3 mm and 4 mm, each of 20 mm length. To ensure access to small and distal vessels both versions are compatible with 0.0165-inch ID microcatheters (e.g. Boston Scientific Excelsior SL-10, Codman Prowler 14) and can be used in minimum vessel diameters of at least 1.5 mm.

The pREset Lite 4-20 is the first 4mm device for the intracranial retrieval of thombi that can be used in small catheters, according to  James Lago, consultant vice president of International Marketing and Sales at phenox.

“Vessel occlusion often extends far distal in the cerebral vasculature. Critical decisions have to be taken whether to proceed with the procedure accepting a significant risk of hemorrhage or to stop accepting incomplete recanalization and worse functional recovery,” said Wiebke Kurre, M.D., senior physician at Katharinen Hospital in Stuttgart, Germany. “The low profile, low radial force pREset Lite allows for safer catheterization and thrombectomy in small vessels.”

Based in Bochum, Germany, Phenox develops technologies and solutions for neurovascular disease treatment. The company was founded in 2005.