Seamless solutions for every stage of your cardiovascular device journey
From Generation 1 to Generation 3 and Beyond, We’re Your Partner at Every Milestone.
Veranex is the only MedTech CRO that integrates design, manufacturing, preclinical, and clinical investigation capabilities—guided by regulatory & commercialization expertise—to advance your cardiovascular device from concept to commercialization. By offering seamless transitions within a single partner, we eliminate inefficiencies, save valuable time, and reduce costs—enabling our sponsors, like you, to focus on innovation that transforms patient care.
Case Study: TAVI Delivery System
Situation
In response to evolving market demands due to increasing prevalence of aortic stenosis disorder, our client was determined to improve their transcatheter aortic valve implantation device (TAVI) to become the preferred standard by surgeons.
Successes
- 175 initial concepts generated, reduced to 5 compelling directions that lead to the 1 selected delivery system.
- We harvested thought leader and end user feedback from multiple geographies (US, Germany, and Netherlands) to inform sponsor and solution positioning to drive market competitiveness.
- Veranex produced rapid prototypes with benchtop testing, to expedited development of final fit and form, leading to best-in-class solution that is gaining market share today.
- 16 months from project initiation to design freeze
Services by Veranex
- Early discovery
- Product design ideation
- Rapid prototyping and testing
- Human factors and usability testing
- Product design refinement
Case Study: Pulse Field Ablation Preclinical Study
Situation
A large-animal model GLP preclinical study was needed to support a 510(k) submission for the next generation of an electrophysiology (EP) device, specifically with pulsed field ablation (PFA).
Successes
- The sponsor leveraged Veranex’s PFA expertise to design and execute a large-animal GLP study.
- We leveraged our in-house DVM to guide execution and delivery of the PFA in model supporting sponsor's staff.
- Safety criteria was met and summarized into a report after a 30-day checkup and histopathology results.
Services by Veranex
- Preclinical Services | Paris, France
- Preclinical Services | Atlanta, GA
- Histology | Worcester, MA
Case Study: TAVR Preclinical Study
Situation
TAVR is known to migrate in animals, we created an ovine model of aortic calcification to support TAVR.
Successes
- The team leveraged their expertise to execute a cardiopulmonary bypass open-heart approach to perform annuloplasty that spared the native aortic leaflets. Two weeks later the TAVR was successfully completed.
- Leveraged in house DVM to support the Sponsor’s staff to execute study.
- The data collected demonstrated chronic performance of the valve and the acute performance of the delivery system to support an FDA submission.
Services by Veranex
- Preclinical Services | Paris, France