Imperative Care has announced the initiation of a first-in-human (FIH) clinical study for its novel stent system designed to only require single antiplatelet therapy for patients undergoing stent-assisted treatment of wide-neck intracranial aneurysms.
The first three patients enrolled were successfully treated by Nobuyuki Sakai (Kobe City Medical Center General Hospital, Kobe City, 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,” said Sakai. “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.”
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 programme is neurovascular disorders, beginning with wide-neck aneurysms. The company intends to investigate versions of the stent for a wider scope of haemorrhagic and ischaemic stroke-related conditions too, as per a press release.
“A single antiplatelet stent, which is designed to allow patients to be managed solely on aspirin, will be a gamechanger for patient outcomes and in the practice of neurointerventional surgery,” said Aquilla Turk (Greenville Health System, Greenville, USA), Imperative Care’s chief medical officer. “By aiming to eliminate the trade-off 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 haemodynamically optimised nitinol architecture with a proprietary coating that naturally resists clot formation,” added Fred Khosravi, chairman and chief executive officer of Imperative Care. “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 innovative and critically important 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.”