Services
Because it Needs to be Done Right Every Time
From safety to FDA strategy and support, our team of experts all have first-hand experience with industry leaders. They understand how to balance the benefit-risk ratio with the practicalities of regulatory compliance. Because Vascular Breakthroughs, through our partnership with The Vascular Care Group, performs preclinical studies, clinical research, and facilitates diverse patient enrollment in studies year-round, our team comes to each project with a well-informed sense of what the US FDA and other regulators expect to see.
Consulting, Strategy and Training
Whether pursuing commercialization of a new medical device in the US or meeting post-market data with requirements for a commercialized device, our team can help provide you the clinical expertise, research plan, and data for successful FDA submissions. We provide product development support with a large pool of subject matter experts. With training facilities throughout New England we are able to organize meetings and clinical training events to support the launch of new technologies.
Pre-Clinical Research
When it comes to successful preclinical testing of medical devices, experience matters. Vascular Breakthrough’s preclinical research services allow you to evaluate your product or device for safety and performance. Our team is experienced at designing and executing studies to bridge preclinical safety endpoints to proposed clinical endpoints, allowing clinical labs to standardize measurements and obtain expert interpretations of results. We offer extensive expertise to assist in pre-market bench-top testing, protocol review for feasibility and enrollment barriers, and FDA consulting to streamline your approval process
Vascular Breakthrough’s surgical team — including board-certified vascular surgeons and interventional radiologists — are equipped with the necessary tools to support your entire procedure. When you need thorough laboratory research or preclinical testing of medical devices, we have the technology and experience needed to successfully execute your study.
Vascular Breakthrough’s surgical team — including board-certified vascular surgeons and interventional radiologists — are equipped with the necessary tools to support your entire procedure. When you need thorough laboratory research or preclinical testing of medical devices, we have the technology and experience needed to successfully execute your study.
Read More
Read Less
Clinical Research
As one of the world’s leading vascular research organizations, our expertise spans every manner of vascular disease, therapy and technology. This broad range of experience allows us to successfully lead our clients through all phases of clinical research: from first-in-human, IDE trials, Investigator-initiated, pivotal and post-market registry and post 510(k) product market testing. Vascular Breakthroughs also provides clients with direct access to vascular care networks to conduct safe, effective and efficient clinical trials, which are optimized to achieve clean data, regulatory approval, and promote new opportunities for innovation.
We have broad experience with vascular-focused research and trial experience for numerous disease processes, such as PAD, Dialysis Access, Wound Healing, Deep Vein Disease, Varicose Veins, and Vascular Malformations.
We have broad experience with vascular-focused research and trial experience for numerous disease processes, such as PAD, Dialysis Access, Wound Healing, Deep Vein Disease, Varicose Veins, and Vascular Malformations.
Real-World Data
At Vascular Breakthroughs, real-world data is a core part of how we accelerate discovery and improve outcomes. Through our partnership with The Vascular Care Group, we capture hundreds of discrete data elements as part of routine patient care. This structured, high-quality data helps expedite trial activation, improve patient selection, and support meaningful endpoint analysis.
Because data is captured through standardized care pathways, we ensure consistency and clinical relevance across all studies. From baseline demographics to long-term outcomes, our data enables early signal detection, real-time monitoring, and informed decision-making.
By integrating research into clinical care, we deliver actionable evidence that advances innovation, enhances trial performance, and supports regulatory confidence.
Because data is captured through standardized care pathways, we ensure consistency and clinical relevance across all studies. From baseline demographics to long-term outcomes, our data enables early signal detection, real-time monitoring, and informed decision-making.
By integrating research into clinical care, we deliver actionable evidence that advances innovation, enhances trial performance, and supports regulatory confidence.
Read More
Read Less