Study Begins of Implant Enabling Post-Aneurysm Single Antiplatelet Therapy

Imperative Care has initiated a first-in-human clinical study of its stent system designed to enable single antiplatelet therapy to patients undergoing stent-assisted treatment of wide-neck intracranial aneurysms.
 
The first three patients enrolled were successfully treated by Dr. Nobuyuki Sakai, director of Neurosurgery at the Kobe City Medical Center General Hospital in Kobe City, Hyogo, Japan. All three patients underwent planned procedures for stent-assisted coiling of unruptured aneurysms, and all three were discharged from the hospital within 48 hours on an aspirin-only antiplatelet regimen and without any 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,” Sakai said. “I am encouraged by these positive early results with Imperative Care’s stent technology and look forward to future investigations in a wide range of patients, including those with ruptured aneurysms.”
 
The company’s 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 the company’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.
 
“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,” stated Aquilla Turk, D.O., Imperative Care’s chief medical officer and practicing neuroendovascular surgeon at Greenville Health System in South Carolina. “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.” 
 
“We are pleased with the progress to date with our neurovascular stent, which combines a hemodynamically-optimized nitinol architecture with a proprietary coating that naturally resists clot formation,” Imperative Care Chairman/CEO Fred Khosravi said. “There is a great deal more work to be done to bring a single antiplatelet stent to patients, but we are deeply committed to making this technology a major force in future neurovascular treatments. In addition to the neurovascular applications, we believe that a single antiplatelet stent could make an important contribution in other targets within the vascular system.”
 
Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for people affected by vascular diseases such as stroke and pulmonary embolism. The company has four businesses focused on addressing specific gaps in treatment and care to make an impact across the entire patient journey. Imperative Care is based in Campbell, Calif. 

The Neurovascular Stent System is not yet approved for commercial use.