Amplitude Vascular Systems (AVS), developer of the Pulse intravascular lithotripsy (IVL) platform, and the Jacobs Institute, a non-profit medical device innovation centre in Buffalo, USA, are set to partner on a study of the Pulse IVL system.
This partnership will execute clinical studies evaluating the system in both coronary and carotid vasculatures, and aims to expand clinical indications for the Pulse IVL system.
Pulse IVL is an IVL device that uses high-frequency pressure waves to fracture calcium with a non-compliant balloon to expand the vessel.
This partnership combines the clinical and regulatory capabilities of the Jacobs Institute with the novel lithotripsy technology from AVS to potentially expedite the time to market for coronary and carotid indications of the Pulse IVL system, the organisations have stated in a press release.
“The Jacobs Institute and Adnan Siddiqui [Buffalo, USA] are well positioned to assist companies in the regulatory approval journey,” said Mark Toland, chairman of the board of AVS. “Dr Siddiqui and the team at the Jacobs Institute are committed to bringing novel technologies to market through their vertically aligned infrastructure, which accelerates the pathway from development to clinical trials, to commercialisation. We are excited to partner with the Jacobs Institute on expanding the use of the Pulse IVL system in coronary and carotid lesions.”
The joint effort between AVS and the Jacobs Institute will strive to create a new treatment option for stroke patients and potentially lighten the burden of death and disability caused by stroke, the press release adds.
“We believe the Pulse IVL system is the perfect fit for the structure we’ve built at the Jacobs Institute,” said Siddiqui. “By fostering an environment that nurtures innovation, the Jacobs Institute will help to bring this technology to patients sooner, ultimately providing better treatment options for patients with coronary and carotid artery diseases. We are especially excited about studying the Pulse IVL system in carotids to improve stroke care. We believe its unique mechanism of action may be an important solution for the diffuse and eccentric nature of many of our carotid disease patients.”
AVS recently received approval from the US Food and Drug Administration (FDA) to start a US investigational device exemption (IDE) peripheral vascular clinical trial for IVL. The POWER-PAD-II trial is expected to start enrolment in the coming weeks at up to 20 US centres.
