Wednesday, May 21, 2025
5/21/2025
Magnetic Rotational Platform for Coronary Lesions - Cardiovascular disease (CVD) is the leading cause of mortality in the United States (US), resulting in 850,000 annual deaths, of which nearly 400,000 are associated with coronary heart disease (CHD) and myocardial infarction (MI). By 2030, global annual deaths will exceed 20 million. More than 90 million US adults currently live with CVD, which is associated with an annual economic burden of more than $330 billion. Together, MI and CHD are the most expensive conditions treated in US hospitals, totaling more than $20 billion each year, with costs expected to double by 2030. Percutaneous coronary intervention (PCI) is an effective strategy to restore blood flow for obstructive CHD. However, while nearly 950,000 PCI procedures are performed each year in the US, navigating tortuous vessels is challenging and enabling stent expansion within severely calcified occlusions often fails, which are observed in ~35% and ~20% of procedures, respectively. Rotational atherectomy (RA) and orbital atherectomy (OA) are increasingly used to debulk otherwise untreatable lesions to enable PCI, with recent studies confirming RA and OA improve stent deliverability vs. standard PCI without negatively affecting outcomes. To debulk severely calcified lesion, RA/OA devices employ long (>300cm) stiff driveshafts which spin burrs/crowns at speeds up to 180,000 RPM. For both RA and OA, the inflexible driveshaft often hinders access within tortuous vasculature. The high speeds employed are necessary to stabilize the burr/crown about a guidewire, without which, the tip would dangerously whip. However, the need for extreme rotational speeds greatly increases the complexity of RA/OA systems and presents risks, which include 1) thermal injury due to driveshaft friction, 2) arterial abrasion and perforation, 3) guidewire shattering, 4) burr/crown entrapment, and 5) embolic debris within the distal vasculature. To reduce the risk of traumatic injury, RA and OA devices cannot be used for more than five minutes. UN&UP has developed a magnetic rotational atherectomy platform that includes an over-the-wire atherectomy device that is controlled using magnetic fields 100X weaker than an MRI. Applying magnetic forces directly to the burr eliminates the need for 100X higher driveshaft speeds to stabilize tip rotation. Resultingly, safer and more efficacious debulking is achieved. As confirmed by testing at Dr. Yihao Zheng’s preeminent lab at Worcester Polytechnic Institute, magnetic grinding at 1200RPM produced smaller debris without any thermal heating, in contrast to RA and OA devices which require >100,000RPM. For the proposed effort, the current prototype magnet system will be enclosed in a protective shroud and mounted on the company’s portable multi-axis robotic arm, and the current prototype atherectomy catheter will be improved to enable selective profile grinding and 3D localization. Following professional in vitro efficacy assessments at Dr. Yihao Zheng’s lab, large animal safety and feasibility comparative studies will be conducted at NASMA, a leading CRO with expertise in the proposed animal model.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).