Peripheral CTOs
Peripheral CTOs (Chronic Total Occlusions) are common in advanced PAD, with high failure rates in crossing. Calcified CTOs — especially in the femoropopliteal and infrapopliteal segments — can challenge even experienced operators.
Home / The Need
A major unmet medical need.
Peripheral Arterial Disease affects over 200 million patients worldwide. When calcified occlusions can’t be crossed, limbs are at risk.
Peripheral Arterial Disease
Vision: Reduce Amputations
PAD affects > 200 Million patients worldwide and over 12 million in the United States.
PAD narrows the arteries that carry blood to the legs. In its most advanced form, Chronic Limb Threatening Ischemia (CLTI), the limb is at serious risk — particularly among patients with diabetes and chronic kidney disease.
Many patients with advanced disease have highly calcified, complete occlusions that are difficult or impossible to cross with existing tools. When a wire can’t cross, revascularization can’t begin.
Solving a Major Unmet Medical Need
Why crossing matters.
CLTI
CLTI (Chronic Limb Threatening Ischemia) is the most advanced and serious form of PAD. Failed crossing can mean incomplete revascularization, persistent ischemia and a high risk of amputation.
What clinicians need
Clinicians need a safer, more effective, less traumatic, and time saving crossing option.
By the numbers
The cost of limb loss.
10–12M
Americans have PAD. Many have highly calcified, complete occlusions (CTOs).
~150K
preventable amputations each year in the U.S.
~3.1 yrs
median survival after major amputation.
$6.31B
annual U.S. hospital cost burden for preventable PAD amputations.
8.7%
30-day mortality after major amputation
28.9%
1-year mortality after major amputation
63%
5-year mortality after major amputation
Most amputations are associated with potentially preventable limb loss. Statistics are drawn from published clinical and health-economic literature.
Our answer
FirstPass is being designed with the CTO in mind.
Ropana Vascular’s FirstPass IVL Catheter is a forward-emitting lithotripsy catheter created as a time saving choice for crossing CTOs more efficiently and less traumatically.*
*Currently under development — not FDA cleared.
For More Information
To learn more about Ropana Vascular’s Regulatory and Development Pathway, connect with us.