The first three enrolled patients received scheduled stent-assisted coiling procedures and were treated successfully at Hyogo, Japan-based Kobe City Medical Center General Hospital
Imperative Care has started trial of its novel implant for aneurysm treatment. (Credit: Online Marketing on Unsplash)
Medical technology company Imperative Care has started the first-in-human (FIH) clinical study of its novel stent system on patients undergoing treatment of wide-neck intracranial aneurysms.
The investigational stent system is a coated, low-profile nitinol scaffold system. It is designed as a platform technology for several vascular applications.
According to Imperative Care, the system enables only single antiplatelet therapy for patients under stent-assisted aneurysm treatment. It avoids the complications of dual antiplatelet therapy.
The first three enrolled patients were treated successfully by Nobuyuki Sakai, neurosurgery director at the Hyogo, Japan-based Kobe City Medical Center General Hospital.
In the study, all three patients received scheduled stent-assisted coiling procedures for unruptured aneurysms.
All of them were released from the hospital 48 hours later with an antiplatelet regimen consisting solely of aspirin, without any problems associated with the procedure or device, including the formation of clots.
Sakai said: “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.
“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 clinical development programme of the medical technology firm initially targets neurovascular illnesses, starting with aneurysms of the broad neck.
Imperative Care plans to assess stent variants for a broader range of disorders connected to ischemic and haemorrhagic strokes.
Imperative Care chairman and CEO Fred Khosravi said: “We are pleased with the progress to date with our neurovascular stent, which combines a hemodynamically-optimised nitinol architecture with a proprietary coating that naturally resists clot formation.
“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.”