Imperative Care’s Neurovascular Stent System FIH Study Enrolls First Patients in Japan

December 14, 2023—Imperative Care announced the initiation of a first-in-human (FIH) clinical study for its neurovascular stent system. The device is designed to require single antiplatelet therapy for patients undergoing stent-assisted treatment of wide-neck intracranial aneurysms.

According to the company, its investigational stent system is a coated, extremely low-profile nitinol scaffold designed as a platform technology for a range of vascular applications. The initial focus of Imperative Care’s clinical development program is neurovascular disorders, beginning with wide-neck aneurysms. The company intends to investigate versions of the stent for a wider scope of hemorrhagic and ischemic stroke-related conditions.

The first three patients enrolled in the FIH study were treated by Nobuyuki Sakai, MD, Director of Neurosurgery at the Kobe City Medical Center General Hospital in Kobe City, Hyogo, Japan.

According to the company, the patients underwent planned procedures for stent-assisted coiling of unruptured aneurysms. All three patients were discharged from the hospital within 48 hours on an aspirin-only antiplatelet regimen. There were no device or procedure-related complications—including clot formation.

“The ability for neurovascular implants to avoid dual antiplatelet drug therapy, which carries the risk of serious bleeding complications, will be an important step forward,” commented Dr. Sakai in the company’s press release. “I am encouraged by these positive early results with Imperative Care’s innovative stent technology and look forward to future investigations in a wide range of patients, including those with ruptured aneurysms.”

Aquilla Turk, DO, Imperative Care’s Chief Medical Officer and a practicing neuroendovascular surgeon at Greenville Health System in Greenville, South Carolina, stated, “A single antiplatelet stent, which is designed to allow patients to be managed solely on aspirin, will be a game-changer for patient outcomes and in the practice of neurointerventional surgery.”

Dr. Turk continued, “By aiming to eliminate the tradeoff between the risk of clot formation without dual antiplatelet therapy and bleeding complications with antiplatelet therapy, the Imperative Care stent could represent a platform technology with improved safety and broad applications in neurovascular disorders beyond unruptured aneurysms.”