phenox receives CE Mark approval for pREset® LITE Thrombectomy Device

With the pREset LITE phenox expands its innovative product portfolio by offering physicians new options for the intracranial treatment of ischemic stroke

Bochum, (PresseBox) - phenox® GmbH has been granted CE Mark approval for pREset® LITE Thrombectomy Device for commercialization within the European Union and any country that accepts CE Mark approval. With the pREset LITE phenox expands its innovative product portfolio by offering physicians new options for the intracranial treatment of ischemic stroke.

Dr.-Ing. Hermann Monstadt, Managing Director at phenox GmbH, comments, "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. It is based on the design of the pREset thrombectomy device which has proven its high clinical effectiveness in many hundred cases." With the new pREset LITE, the pREset, BONnet and BONnet short devices phenox GmbH now offers the broadest 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 undoubtly the pREset LITE, a three and four mm stent retriever that navigates through a 10-microcatheter," Dr. Vitor Mendes Pereira, Head of Interventional Neuroradiology at University Hospital of Geneva, Switzerland says. "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. It is impressive how the technical evolution is pushing forward the acute stroke therapy field. Great new tool!"

Like the phenox pREset thrombectomy device the pREset LITE has a proximal closed "ring" design. This ensures a stable opening, reduces tapering when withdrawn and provides optimized distribution of radial force. Together with its helically shaped slit the pREset LITE facilitates the safe and effective treatment of ischemic stroke. The pREset LITE is available in two sizes with diameters of three and four mm, each of 20 mm length. To ensure access to small and distal vessels both versions are compatible with 0.0165" 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.

According to Mr. James Lago, Consultant Vice President International Marketing & Sales at phenox GmbH, "the pREset LITE 4-20 is the first 4mm device for the intracranial retrieval of thombi that can be used in such small catheters". Dr. Wiebke Kurre, senior physician at Katharinenhospital in Stuttgart, Germany, comments: "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. The low profile, low radial force pREset LITE allows for safer catheterization and thrombectomy in small vessels. Clincal experience with pREset LITE convinced me and I would not want to miss this device in my stroketoolbox." The pREset device has just further proven its safety and efficacy in a review of 271 consecutive cases.*

*Kurre et al. (2014): Clinical experience with the pREset stent retriever for the treatment of acute ischemic stroke - a review of 271 consecutive cases. Neuroadiology, March 2014. Berlin, Heidelberg: Springer.

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phenox GmbH

Since its founding in 2005, phenox has been dedicated to developing innovative, breakthrough and clinically proven technologies and solutions for the treatment of neurovascular diseases. phenox's products are used by endovascular specialists to treat ischemic and hemorrhagic stroke. The company offers a growing portfolio of innovative treatment options, including the primary interventional technologies used today - the BONnet, BONnet short, pREset and pREset LITE Thrombectomy Retriever, the LIR Aspiration Catheter, the p64 Flow Modulation Device and the pCONus Bifurcation Aneurysm Implant. Phenox is a privately held company financed with private funds and by NRW. BANK. Venture Fond GmbH & Co.KG. together with SHS Technologiefonds GmbH & Co.KG. More information about the company and its products can be found at www.phenox.info.

phenox, BONnet, pREset, pCONus, p64 and p64 Flow Modulation Device are trademarks of phenox GmbH, registered in Germany and other countries. All other trademarks and trade names referred to in this press release are the property of their respective owners.

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