Piedmont Atlanta treats first intracranial aneurysm patients in Southeast in PIANO Trial

PIANO IDE Trial

Piedmont Atlanta Hospital announced the successful treatment of the first patients in the Southeast enrolled in the p48 and p64 MW HPC in Aneurysm Occlusion (PIANO) IDE Trial, evaluating the p48 and p64 MW HPC Flow Modulation Devices for the treatment of intracranial aneurysms.

Piedmont is the third U.S. site to enroll in the PIANO Trial and the first site in the Southeast to perform these procedures. The first two cases were performed by Michael F. Stiefel, M.D., PhD, System Medical Director of Piedmont’s Stroke Program and Director of Cerebrovascular and Endovascular Neurosurgery and the Comprehensive Stroke Center at Piedmont Atlanta.

Dr. Stiefel is joined in the PIANO IDE Trial by A. Jesse Schuette, M.D., and David I. Bass, M.D., PhD, who serve as co-investigators and are part of Piedmont’s Cerebrovascular and Endovascular Neurosurgery team participating in the study.

“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 United States demonstrating consistently high aneurysm occlusion rates and low complication rates,” said Dr Stiefel.

Flow diversion has become an established therapy for intracranial aneurysms, though device options for U.S. physicians remain limited. The p48 and p64 MW HPC flow diverters are widely utilized internationally and are market leaders in Germany.

“We are excited to evaluate a next-generation device that has the potential to further expand how we treat intracranial aneurysms,” said Dr. Stiefel. “The combination of enhanced deliverability, visibility, and innovative design features may provide important procedural advantages while helping us continue to deliver safe, evidence-driven care to our patients through participation in this clinical trial.”

Both patients involved in the first two cases did very well during and after the procedure and were discharged home the following day.

The p48 and p64 MW HPC Flow Modulation Devices are investigational devices in the United States and are limited by federal law to investigational use.