R43HL158306

Magnetic Rotational Exploratory 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.

Unandup has developed an interventional cardiology platform consisting of a magnetic access guidewire and an over-the-wire rotational atherectomy catheter which are controlled using magnetic fields 100x weaker than an MRI.

The magnetic guidewire overcomes vessel tortuosity to improve lesion access, a desirable feature for PCI in general. For the magnetic atherectomy catheter, 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.

Further, driveshaft removal enables concurrent aspiration of embolic debris near the burr, a feature not possible with current atherectomy devices.

The team reflects leading cardiology, RA/OA, magnetics, and robotics experts. The company maintains partnerships with leading national laboratories and recently completed an FDA presubmission meeting and I-Corps participation.

The proposal's aims include building a prototype magnet system, building magnetic guidewire and atherectomy devices, and evaluating the system's performance in tortuous cardiac phantoms and published lesion models.

Unandup

NOT APPLICABLE

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Missouri United States

State-Wide

PHS 2020-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) (PA-20-260)

Amendment Since initial award the End Date has been extended from 12/31/22 to 12/31/23 and the total obligations have increased 2% from $456,397 to $465,097.