Peripheral CTOs
Peripheral CTOs (Chronic Total Occlusions) are common in advanced PAD, with high failure rates in crossing.
Innovative FirstPass™ Technology
Forward emitting peripheral IVL — built to help reduce amputations.
Ropana Vascular develops innovative endovascular devices for effective vascular treatment of cardiovascular disease.
FirstPass is under development — not FDA clearedConcept animation, not to scale: energy delivered forward from the catheter tip into a calcified occlusion.
200M+patients with Peripheral Arterial Disease (PAD) worldwide
12M+patients with PAD in the United States
~150Kpreventable amputations each year in the U.S.
Mission
Filling significant unmet clinical needs.
At Ropana Vascular, we develop endovascular devices to fill significant unmet clinical needs in the treatment of cardiovascular disease.
Vision
Reduce Amputations
Peripheral Arterial Disease (PAD) affects > 200 Million patients worldwide and over 12 million in the United States.
The Need
Solving a Major Unmet Medical Need
CLTI
CLTI (Chronic Limb Threatening Ischemia) is the most advanced and serious form of PAD.
A better crossing option
Clinicians need a safer, more effective, less traumatic, and time saving crossing option.
Ropana Vascular’s FirstPass IVL Catheter is being designed with the CTO in mind!
FirstPass™*
IVL technology created as a time saving choice for crossing CTOs more efficiently and less traumatically.
*Currently under development — not FDA cleared.
Fracture.
Break through the calcified barriers that prevent crossing.
Flow.
Enable crossing and restore blood flow to the limb.
Freedom.
Give patients the opportunity for mobility, independence and a life without limb loss.
Concept animation, not to scale. FirstPass is under development and not FDA cleared.
How it works
Fracture the cap. Cross the lesion.
- A 100% calcified blockageThe wire cannot cross the plaque.
- End-emitting IVL catheterEnergy is delivered forward from the catheter tip.
- The catheter advances, creating a channelPulses fracture the calcium ahead of the tip.
- The wire can now crossThe catheter is withdrawn, a guidewire passed, and standard revascularization therapy can follow.
Where we are
From prototype to patients.
Under Development
Based on functional bench testing and visual inspection, our end-emitting lithotripsy catheter crossed both gypsum models and calcified human artery specimens.
Next Phase
- Currently refining the prototype, with human artery specimen testing and ongoing development of the console/generator.
- Additional sizes for above and below the knee applications.
- Strategic work on patents — provisional and applied.
Path Forward
- Commercialize to profitability, disruption, and exit options.
- FDA clearance — Go to market.
- Commercialization leadership team is already in place. Revenue ramp focus on capturing growing peripheral CTO/IVL market, specifically in OBLs and ASCs.
Leadership
Experienced leadership. Clinician-led.
Vijay Ramanath, MD, FACC, FSCAI
Founder and Chief Medical Officer (CMO)
Ropana Vascular Founder.
Interventional Cardiologist with 15+ years of clinical expertise, with an entrepreneurial mindset and multiple patents.
James Lowry
Chief Executive Officer (CEO)
35 years of leadership in medical device sales, marketing and consulting to startups, scaleups and global corporations.
Jim Harrison, BS, MS
Chief Technology Officer (CTO)
A proven track record of delivering innovative medical devices that transform patient care. He has led teams to 18 clinical trials, 10 IDE approvals, and 3 PMA Class III approvals while driving two acquisitions exceeding $500M and mentoring high-performing R&D teams.
Robert Dorsher, MBA
Chief Operating Officer (COO)
40 years of medical device leadership in strategic commercialization, operations and planning.
Clinical Advisors and Key Opinion Leaders
Guided by leading vascular specialists.
Interventional cardiologists, vascular medicine physicians and endovascular surgeons from leading institutions advise the FirstPass program.
Meet the advisors
For More Information
To learn more about Ropana Vascular’s Regulatory and Development Pathway, connect with us.