helping patients with calcified plaque in arterial walls
Atherosclerosis is the accumulation of plaque within arterial walls leading to the narrowing (or stenosis) of the artery. Over time, this plaque may become calcified, resulting in a higher risk of cardiovascular disease and other complications.
In the United States, an estimated 10 million potential patients are affected, and this number is expected to grow with the aging population. Standard of care balloon angioplasty techniques have limited efficacy once plaque becomes calcified, and various aggressive strategies are often used to treat these patients. However, these procedures have associated costs and risks, including possible vessel dissection and rupture and restenosis.
A University of Michigan research team led by Hitinder Gurm, M.D., Albert Shih, Ph.D., and Robert Chisena, Ph.D., developed an improved calcified plaque treatment method that incorporates the simplicity of conventional balloon angioplasty with lithotripsy balloon angioplasty, a proprietary balloon oscillation technique. The system uses cyclical pressure waves generated in the angioplasty balloon to gently disrupt the calcified plaque and expand the vessel.
“Treating calcified plaque can be difficult, expensive, and can require additional clinician training and specialized equipment,” said Gurm. “There exists a need for a surgical device that is safe, easy-to-use, and effective.”
The team also expects the device to be successful in treating calcifications within previously deployed stents, a medical problem that currently has no approved treatment options.
Significant Need
Current treatment strategies for calcified plaque can be difficult, expensive, and result in damaging complications.
Compelling Science
Hydraulic-lithotripsy uses high-frequency pressure oscillations to induce fatigue and stress that leads to disruption and fracturing of the plaque.
Competitive Advantage
The device is expected to reduce calcified plaque fracture pressure, resulting in less pressure-induced trauma and vascular injury. It will also reduce the need for additional procedures such as stenting or atherectomy.
Overall Commercialization
- Intellectual Property – PCT and continuation-in-part published covering device design and method of use.
- Commercialization Strategy – A company was formed to develop the device through first-in-human (FIH) study, with the goal of acquisition by an established medical device company. Intellectual property is being licensed.
- Regulatory Pathway – FDA IDE submission for FIH study, FDA 510(k) device clearance with identified predicates.
- Product Launch Strategy – Initial clinical indication in peripheral artery calcified plaques with subsequent expansion into coronary arterial calcifications and under-expanded stents.
Milestones
- Component and frequency control development
- Injury comparison in healthy animal iliac arteries treated with the device and standard balloon angioplasty
- Efficacy testing in cadaveric calcified plaque
- Reimbursement strategy consulting
- Design controls consulting and device manufacturing in preparation of an FDA Pre-submission meeting
