WallabyPhenox announced today that the first US patients have successfully been treated in the PIANO investigational device exemption (IDE) trial evaluating the company’s p48 and p64 MW Hydrophilic Polymer Coating (HPC) flow-modulation devices for intracranial aneurysms. The first two procedures were performed by Adel Malek at Tufts Medical Center (Boston, USA).
“We always welcome the opportunity to offer new innovations and technologies to our patients through cutting-edge clinical trials,” said Malek. “A device that proves to be safe, effective and efficient will only enhance our ability to treat intracranial aneurysms and ensure the best possible outcomes for our patients.”
“Initiating the PIANO IDE trial is an important milestone in our company’s history and demonstrates our commitment to bringing lifesaving innovations to patients in the USA,” added WallabyPhenox chief executive officer (CEO) Ruilin Zhao.
A WallabyPhenox press release notes that, while flow diversion is an established therapy for intracranial aneurysms, limited device options remain available to US physicians. The p48 and p64 MW HPC flow diverters are the market leader in Germany, the release also states.
“The p48 and p64 MW HPC devices have been used in the treatment of more than 20,000 patients worldwide, with data from rigorous studies conducted outside the USA demonstrating consistently high aneurysm occlusion rates and low complication rates,” said Gary Brogan, vice president of global clinical and regulatory affairs at WallabyPhenox.
The p48 and p64 MW HPC devices bring with them “multiple novel features”, including the first ‘Movable Wire’ technology designed for stable and controlled positioning as well as the HPC surface modification intended to reduce the thrombogenicity of the implant. Smaller microcatheter delivery simplifies procedural access, while the nitinol wires with a platinum core provide full radiographic visibility, WallabyPhenox also claims.
“We are pleased to usher in this unique flow diverter that the US physician community has been eagerly awaiting,” commented Demetrius Lopes (Advocate Health Care, Chicago, USA), who serves as the national principal investigator for PIANO along with Jared Knopman (Weill Cornell Medicine, New York, USA) and Eytan Raz (New York University [NYU] Langone Health, New York, USA).
Enrolment in the PIANO IDE trial is ongoing at leading US centres, according to WallabyPhenox.
The company notes that the p48 and p64 MW HPC flow-modulation devices are currently limited by federal law to investigational use in the USA.
