The Zone Isolation and Bypass System is designed to isolate and stabilize a segment of vessel for treatment while maintaining distal flow of blood, providing clinicians with the opportunity to safely conduct minimally invasive procedures on the vessel wall.
The Zone device is an Endovascular Surgical Platform addressing:
- Many Potential Applications: AAA, TAA, Dissection, Trauma, DOD
- Significant Clinical Need: 40% of aortic procedures remain treated with open surgeries
- Large and Growing Market: $675M, 9%+ annual growth US
Unmet Clinical Need
Currently 40% of aortic procedures are open surgeries. Current endovascular techniques (almost exclusively stent-graft placements) are limited to specific locations inside the aorta. More than 40,000 patients in the US each year are forced to undergo open abdominal and thoracic aorta procedures, many of whom could benefit from an endovascular procedure enabled by the Zone surgical platform
Open aortic surgery present significant challenges:
- Region of high blood pressure
- Increased risk of MI, renal failure, paralysis due to clamping of the aorta
- Main blood supply to vital organs (digestive system)
- Up to a 20% mortality rate with open Thoracic Aorta procedures
Required advancements include:
- Alternative to intraoperative aortic clamping (allow distal perfusion, reduce stress on heart)
- Alternative to aortic stent grafting that will enable endovascular treatments for a wider range of vascular defects and anatomical locations
- Stabilization platform for trauma, acute aneurysm and dissection
Solution
Zone, is a Catheter-Based Endovascular System which:
- Isolates vascular pathology, protecting region from blood flow and pressure
- Enables blood to bypass isolated zone and continue to distal vital organs
- Isolated zone stabilizes patients for advance treatment or transport
- Instrument channels enable use of surgical tools in the isolated zone
- Concentric balloon system ensures reliable endovascular positioning
Study Results
The Zone technology prototype:
- Reduced to 4.5mm diameter delivery catheter
- Isolating balloons expand to seal against 17-19mm diameter vessels
- 100% distal flow maintained, 19mm vessel
- 50% distal flow maintained, 17mm vessel
- Balloons stable under arterial pressure
