Avantec Vascular (a Nipro Company) — Multi-Country LATAM First-in-Human Program for Avantec's Sangria™ Venous Remodeling System

Avantec Vascular Corporation (San Francisco Bay Area, California, USA — now a Nipro company) is a vascular-device innovator developing the Sangria™ Venous Remodeling System. bioaccess® ran the first-in-human / early clinical studies for the Sangria™ system across El Salvador, Mexico, and Colombia — including principal-investigator and site selection, submission of the regulatory dossier for ministry-of-health approvals to conduct the studies, a $10M clinical-trial insurance policy, device importation, and first-in-human study execution. The Sangria™ system is investigational; nothing here implies FDA clearance, approval, CE marking, or commercialization of Sangria™.

Study facts

• Sponsor / company: Avantec Vascular (a Nipro Company)
• Indication / area: Cardiovascular / Vascular / Venous
• Country: El Salvador, Mexico, Colombia
• Study type: First-in-Human (FIH)

Key metrics

• Countries: El Salvador, Mexico, Colombia
• Trial Type: First-in-Human (FIH)
• Insurance: $10M policy
• Status: Investigational

The challenge

Avantec needed to move an investigational venous remodeling device into first-in-human clinical experience across multiple Latin American jurisdictions — anchored to a U.S. FDA strategy — while coordinating in-country regulatory and ethics-committee approvals to conduct the studies, principal-investigator and site selection, device importation logistics, and clinical-trial insurance in each country before enrollment could begin.

bioaccess® solution

bioaccess® ran the first-in-human / early clinical studies for the Sangria™ Venous Remodeling System across El Salvador, Mexico, and Colombia. The engagement covered principal-investigator and site selection, submission of the regulatory dossier for ministry-of-health approvals to conduct the studies, a $10M clinical-trial insurance policy, device importation, and first-in-human study execution. Clinical operations were structured under ISO 14155 / ICH E6 good clinical practice and anchored to the sponsor's U.S. FDA strategy, consistent with bioaccess®'s standard first-in-human execution model.

Results

• First-in-human / early clinical study conduct executed across El Salvador, Mexico, and Colombia
• Principal-investigator and site selection completed in each country
• Regulatory dossier submitted to secure ministry-of-health approvals to conduct the studies
• $10M clinical-trial insurance policy structured for the program
• Device importation coordinated in each jurisdiction
• Clinical operations delivered under ISO 14155 / ICH E6 good clinical practice
• Program anchored to the sponsor's U.S. FDA strategy

Frequently asked

What did bioaccess® do for Avantec Vascular (a Nipro Company)?

bioaccess® ran the first-in-human / early clinical studies for the Sangria™ Venous Remodeling System across El Salvador, Mexico, and Colombia.

Where was the Avantec Vascular (a Nipro Company) First-in-Human (FIH) study run?

The Avantec Vascular (a Nipro Company) First-in-Human (FIH) study was executed in El Salvador, Mexico, Colombia by bioaccess® in the cardiovascular / vascular / venous area.

What was the outcome of the Avantec Vascular (a Nipro Company) study?

Reported outcomes for Avantec Vascular (a Nipro Company)'s device: First-in-human / early clinical study conduct executed across El Salvador, Mexico, and Colombia; Principal-investigator and site selection completed in each country; Regulatory dossier submitted to secure ministry-of-health approvals to conduct the studies.

Run a similar trial: Clinical trials in El Salvador · Clinical trials in Mexico · Clinical trials in Colombia

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