Cardiovascular disease remains the leading cause of death globally — and the demand for safe, effective, and innovative technologies has never been greater. At 1MED, we are proud to support transformative clinical research in cardiology, from high-risk interventions to cutting-edge mechanical circulatory support systems.
One such initiative is our full clinical and regulatory oversight for a two-stage investigational study evaluating the safety and performance of the Quantum Perfusion Dual Lumen Cannula.
A Novel Approach to Extracorporeal Perfusion
The study assesses the safety (pilot phase), performance, and usability (Pivotal Phase) of a dual lumen cannula designed to optimize extracorporeal perfusion, a life-saving intervention for patients with acute cardiac and/or respiratory failure.
The cannula’s dual lumen configuration allows simultaneous venous drainage and reinfusion, streamlining circuit flow and reducing the need for multiple vascular access points. This design aims to enhance procedural efficiency, lower complication rates, and improve clinical control during ECMO and similar therapies.
1MED’s Expertise in Action
As the strategic clinical research partner, 1MED provides comprehensive support, including:
- Regulatory Strategy & Submissions: Enabling CE-marking and MDR compliance
- Protocol Design & Clinical Operations: Managing the full clinical investigation lifecycle
- Site & Investigator Management: Ensuring site readiness and protocol compliance
- Monitoring & Data Integrity: Upholding GCP standards and real-time quality oversight
- Risk & Safety Oversight: Managing adverse event reporting and patient protection measures
Enabling Smarter Pre-Market Development
As a pre-market study, the trial is critical to the device’s regulatory approval and eventual commercial launch. The clinical data will guide decisions related to labeling, risk management, and post-market surveillance.
With deep regulatory knowledge and operational excellence, 1MED ensures this promising cardiological innovation advances safely, efficiently, and in full compliance with evolving EU regulations.
Committed to Cardiovascular Innovation
This project reflects 1MED’s ongoing dedication to enabling breakthroughs in cardiovascular care and sophisticated medical devices, where regulatory requirements and clinical endpoints differ significantly from those of drug trials.
We support medtech innovators at every stage — from early clinical trials to market readiness — helping bring life-saving therapies to the patients who need them most.
1MED Role in Cardiovascular Clinical Trials: Bridging Innovation in Medical Devices and Pharmaceuticals
1MED, a specialized clinical research organization, is playing an increasingly prominent role in advancing cardiovascular therapies. With strong expertise in the management of complex clinical trials, the company has recently distinguished itself in two major areas of therapeutic development: innovative medical devices and pharmaceutical products targeting cardiovascular diseases.
Commitment to Cardiovascular Drug Trials
In parallel, 1MED is actively involved in various clinical trials for cardiovascular drugs, targeting conditions such as:
- Heart failure,
- Resistant hypertension,
- Acute coronary syndromes and angina pectoris ,
- Post-myocardial infarction secondary prevention.
- Aortic and Carotid surgery
The company supports all phases of drug development (from Phase I to Phase IV), with particular focus on:
- Stratification of high-risk patients,
- Close monitoring of efficacy and safety endpoints,
- Advanced biostatistical interpretation of trial data.
With its network of specialized investigators and digital tools for patient follow-up, 1MED ensures rigorous evaluation of novel therapies—whether for first-in-class compounds or enhancements of existing treatments.
Conclusion
1MED is establishing itself as a key player in cardiovascular research by combining the scientific rigor required for pharmaceutical trials with the regulatory complexity of medical device development. Its dual expertise enhances the translation of innovation into clinical practice, ultimately improving care for patients with cardiovascular diseases.