Swiss medtech company Novostia completes enrollment in the PILATUS first-in-human study for their TRIFLO mechanical heart valve — designed to eliminate lifelong anticoagulation.
April 10, 2026
10
min read
By
bioaccess® Team
In short
Novostia’s TRIFLO mechanical heart valve completed 10-patient enrollment in the PILATUS first-in-human study (NCT06119607), with 100% procedural success. The valve is designed to eliminate lifelong anticoagulation — the key limitation of mechanical valves. An 18-month follow-up and 5-year durability program are underway.
**Key Takeaways**
- • Novostia (Swiss medtech) developed the TRIFLO mechanical heart valve to eliminate lifelong anticoagulation
- • PILATUS FIH study (NCT06119607): first implant December 2023, 10 patients enrolled by May 2024
- • All surgeries successful — 100% procedural success rate (see our FDA acceptance guide for Latin American first-in-human studies)
- • 18-month follow-up plus 5-year durability program underway
- • CHF 5.6M raised in September 2024 for continued development
What Is the TRIFLO Mechanical Heart Valve?
Novostia, a Swiss medtech company, has developed the TRIFLO mechanical heart valve — a next-generation prosthetic valve with a revolutionary design goal: to eliminate the need for lifelong anticoagulation therapy. Current mechanical heart valves require patients to take blood thinners indefinitely, exposing them to significant risks of bleeding complications, dietary restrictions, and frequent INR monitoring.
The TRIFLO valve's innovative design aims to achieve hemodynamic performance comparable to or better than existing mechanical valves while dramatically reducing or eliminating thrombogenicity — the tendency to form blood clots that necessitates anticoagulation.
How Was the PILATUS First-in-Human Study Designed?
The PILATUS study (NCT06119607) is the first-in-human clinical evaluation of the TRIFLO valve. The study was designed as a prospective, single-arm trial to assess the safety and feasibility of the device in patients requiring surgical valve replacement.
- ClinicalTrials.gov registration: NCT06119607
- Study design: prospective, single-arm first-in-human
- Primary endpoint: safety at 18 months
- Long-term follow-up: 5-year durability program
- Target enrollment: 10 patients
How Did the 10-Patient Enrollment Achieve 100% Surgical Success?
The first TRIFLO implant was performed in December 2023, and all 10 patients were enrolled by May 2024 — a rapid enrollment pace that reflects strong investigator and patient interest. Most importantly, all surgeries were successful, achieving a 100% procedural success rate.
| Milestone | Date | Details |
|---|---|---|
| First implant | December 2023 | First TRIFLO valve implanted in human |
| Enrollment complete | May 2024 | All 10 patients enrolled |
| Surgical success | 100% | All surgeries successful |
| Funding round | September 2024 | CHF 5.6M raised |
| 18-month follow-up | 2025–2026 | Primary safety endpoint assessment |
Why Does Eliminating Lifelong Anticoagulation Matter?
The potential to eliminate lifelong anticoagulation for mechanical valve patients would represent one of the most significant advances in cardiac surgery in decades. Current mechanical valves — while durable — require patients to take warfarin or similar anticoagulants for life, which carries risks including:
- Major bleeding events (2–4% per year)
- Dietary restrictions and drug interactions
- Frequent INR blood monitoring
- Reduced quality of life and medication burden
- Higher healthcare costs over the patient's lifetime
What Does the 18-Month Follow-Up and 5-Year Durability Program Cover?
Following enrollment completion, all PILATUS patients are being monitored through an 18-month follow-up protocol to assess the primary safety endpoint. Additionally, a 5-year durability program will evaluate the long-term performance and structural integrity of the TRIFLO valve.
How Does bioaccess® Support Cardiac Device FIH Trials in Latin America?
On trial economics, read our Latin America vs US/EU clinical trial cost benchmark.
While the PILATUS study is being conducted in Europe, Latin America has emerged as a strategic alternative for first-in-human cardiac device trials. bioaccess® supports medtech companies with FIH trials for cardiac valves, structural heart devices, and cardiovascular implants across the region.
Latin America offers regulatory timelines of weeks rather than months, lower costs, and access to world-class cardiac surgeons — making it an ideal destination for companies like Novostia looking to accelerate their clinical development programs. Explore our early feasibility study capabilities or learn about market access in the region.
**Developing a novel cardiac device?**
bioaccess® has supported 50+ medtech companies with first-in-human trials in Latin America. Contact bioaccess® today to explore how Latin America can accelerate your cardiac device development, or visit our FIH-12™ page.
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