Supira Medical's First-in-Human Trial in Paraguay: Next-Generation Heart Pump Shows Promise

Supira Medical's percutaneous ventricular assist device has treated 70+ patients in South America with zero bleeding or access site complications — a landmark first-in-human cardiovascular trial initiated in Paraguay.

April 10, 2026

12

min read

By

bioaccess® Team

first-in-human trial Paraguay

Supira Medical

percutaneous ventricular assist device

FIH cardiovascular device

FDA Breakthrough Device

**Key Takeaways**

• • Supira Medical initiated their FIH trial in September 2022 in Asuncion, Paraguay
• • 70+ patients treated in South America with zero bleeding or access site complications
• • FDA Breakthrough Device Designation granted for their percutaneous ventricular assist device
• • US Early Feasibility Study initiated November 2024, SUPPORT II pivotal trial FDA-approved April 2026
• • Latin America chosen for regulatory speed and access to world-class cardiovascular investigators

Trial overview: Supira Medical's next-generation heart pump

Supira Medical, a Shifamed portfolio company, has developed a next-generation percutaneous ventricular assist device (pVAD) designed to provide temporary hemodynamic support during high-risk percutaneous coronary intervention (PCI). The device represents a significant advancement in mechanical circulatory support — an area where innovation has the potential to save thousands of lives each year.

The company's journey from concept to clinical validation began with a bold decision: to conduct their first-in-human clinical trial in Paraguay, leveraging Latin America's regulatory efficiency and world-class cardiovascular surgical talent.

First-in-human trial initiated in Asuncion, Paraguay

In September 2022, Supira Medical initiated their FIH clinical trial at the Italian Hospital in Asuncion, Paraguay. The study was led by Dr. Adrian Ebner, a renowned cardiovascular surgeon with decades of experience in complex cardiac interventions and a track record of supporting innovative device studies.

Paraguay was selected for the FIH study because of its streamlined regulatory approval process, enabling Supira to begin enrolling patients faster than would have been possible through the FDA's Investigational Device Exemption (IDE) pathway. This decision to initiate in Latin America — a strategy employed by an increasing number of US-based medtech companies — proved instrumental in accelerating the development timeline.

• FIH initiated September 2022 at Italian Hospital, Asuncion
• Principal Investigator: Dr. Adrian Ebner, world-class cardiovascular surgeon
• Paraguay selected for regulatory speed and investigator expertise
• Shifamed portfolio company with deep device development experience

70+ patients treated with zero complications

The results from Supira's Latin American clinical program have been extraordinary. Over 70 patients have been treated in South America with the pVAD, and the device has achieved zero bleeding or access site complications — a safety record that is virtually unheard of in the mechanical circulatory support space.

For context, existing pVAD devices on the market are associated with significant rates of bleeding, vascular complications, and hemolysis. Supira's zero-complication rate across 70+ patients represents a potentially transformative safety profile that could redefine the standard of care for hemodynamic support during high-risk PCI.

**Why zero complications matters**

Mechanical circulatory support devices have historically been associated with complication rates of 10–30% for bleeding and vascular access site events. Supira's zero-complication record across 70+ patients in South America suggests a fundamentally different safety profile that could significantly expand the eligible patient population for hemodynamic support during complex cardiac procedures.

FDA Breakthrough Device Designation

Based on the compelling safety data from their Latin American FIH program, Supira Medical received FDA Breakthrough Device Designation for their pVAD. This designation is reserved for devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases and offers several regulatory advantages:

• Priority review and interactive communication with FDA during development
• More flexible clinical study designs and efficient data development
• Prioritized review of premarket submissions
• Senior FDA management involvement in regulatory discussions

US EFS and SUPPORT II pivotal trial

Building on the strong Latin American data, Supira initiated a US Early Feasibility Study (EFS) in November 2024, bringing the device to American patients for the first time. The US EFS represents the next phase in the device's development pathway, generating clinical data under FDA oversight.

In April 2026, the FDA approved the SUPPORT II pivotal trial — the definitive clinical study designed to support regulatory approval for commercial use in the United States. This rapid progression from FIH in Paraguay (2022) to US pivotal trial approval (2026) demonstrates how Latin America can serve as a launch pad for global device development.

Why Latin America for cardiovascular first-in-human trials

Supira Medical's experience in Paraguay exemplifies the strategic advantages of conducting first-in-human cardiovascular device trials in Latin America:

• Regulatory speed: Clinical trial approvals in Paraguay and other LATAM countries take weeks, not months
• World-class investigators: Latin America has exceptional cardiovascular surgeons with international training
• Cost efficiency: FIH trial costs are 40–60% lower than equivalent US studies
• FDA data acceptance: Clinical data from LATAM under ICH-GCP is accepted by the FDA
• Large patient populations: Access to treatment-naïve patients for faster enrollment
• Geographic proximity: South America is easily accessible for US-based sponsors

bioaccess® and FIH trials in Latin America

The Supira Medical story is a powerful example of how Latin America — and countries like Paraguay — have become strategic destinations for first-in-human medical device trials. bioaccess® has supported 50+ medtech companies with FIH trials, early feasibility studies, and market access across the region.

• Regulatory strategy and clinical trial application submissions across LATAM
• Principal investigator identification and site selection
• Ethics committee management and informed consent development
• Full clinical operations: monitoring, data management, safety reporting
• FDA submission support: IDE applications and data packaging

**Ready to launch your FIH cardiovascular trial in Latin America?**

Join Supira Medical and 50+ other medtech innovators who have used Latin America for faster, safer first-in-human studies. Contact bioaccess® today to discuss your FIH strategy, or explore our FIH FastTrack process for accelerated trial setup.

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