Amplitude Vascular Systems wins FDA IDE approval for intravascular lithotripsy study

Amplitude Vascular Systems announced today that it received FDA investigational device exemption (IDE) for its […]

Amplitude Vascular Systems announced today that it received FDA investigational device exemption (IDE) for its pulsatile intravascular lithotripsy (PIVL) therapy.

The POWER-PAD-II clinical study will evaluate the safety and efficacy of the company’s Pulse IVL system. Boston-based Amplitude designed it to treat patients with severely calcified peripheral arterial disease.

IVL is a hot space, highlighted by the recent closing of Johnson & Johnson’s $13.3 billion acquisition of Shockwave Medical. FastWave Medical, another figure in the space, recently reported positive study results for its own IVL technology.

Amplitude designed its IVL system to use pressure waves. Pulse IVL shatters intravascular calcium and expands the lesion to restore blood flow. The company aims to enroll 120 subjects in the trial, will follow-up lasting up to six months. A previous study of the technology already demonstrated benefits to patients with calcific femoropopliteal arteries, including reduced leg pain, increased blood flow and improved ability to walk.

The company also brings significant medtech leadership experience, led by former Corindus CEO Mark Toland as executive chair. Sean Gilligan, a 30-year veteran at Boston Scientific, serves as COO. Gilligan spoke to Medical Design & Outsourcing last year about Amplitude Vascular Systems’ technology.

“We are proud to be one of the first companies to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the U.S.,” Toland said in a news release. “The IDE approval marks our most significant clinical milestone to date as we approach FDA clearance and market availability for the Pulse IVL system, which is designed to easily deliver therapy across complex calcified lesions and reduce overall procedural costs.”

Original article (https://www.massdevice.com/amplitude-vascular-systems-fda-ide-ivl-study/)