HVT Medicals develops a device that enables TAVI (transcatheter aortic valve implantation) in patients where the aortic cusp would otherwise block a coronary artery. Their "Splitter" device aims to expand the applicability of TAVI to a broader patient population currently contraindicated for the procedure.
Funding
Funding not disclosed
Founders
Product
Problem
A significant portion of patients with aortic stenosis are not candidates for transcatheter aortic valve implantation (TAVI) due to the risk of the aortic valve's cusps obstructing coronary arteries. This anatomical limitation prevents these patients from accessing a less invasive treatment option.
Solution
HVT Medical's Splitter device expands the applicability of TAVI by performing controlled cusp splitting prior to valve implantation, mitigating the risk of coronary occlusion. The device, delivered via catheter, employs a cutting head to create a laceration or excision in the valve's cusp tissue. By modifying the aortic valve anatomy, the Splitter enables safer TAVI procedures for patients previously contraindicated due to anatomical limitations, ensuring adequate blood flow to the coronaries. The device integrates into the standard TAVI workflow, allowing interventional cardiologists to intuitively operate the system using fluoroscopy and echo imaging for navigation.
Target Audience
The primary target audience includes interventional cardiologists and hospitals performing TAVI procedures, specifically those treating patients with aortic stenosis who are at risk of coronary obstruction due to aortic cusp anatomy.
Features
- Catheter-based delivery system compatible with standard TAVI guide wires
- Cutting head with jaws designed to grasp and excise the selected leaflet
- Precise control of the cutting site, eliminating the need for extreme pulling force
- Ability to excise a section of the heart valve, creating a window rather than just a slit
- Real-time visualization via fluoroscopy and echo imaging
- Tissue patch removal for positive confirmation of procedure completion
- Design facilitates future coronary access for potential CSI procedures