Cardiovascular Systems Case Studies

Case Study: Developing an Intracardiac Visualization and Intervention Platform

A minimally invasive intracardiac device guidance and delivery system designed to operate under direct, near-field optical visualization.

This platform enables clinicians to perform cardiac interventions with enhanced precision and control, while supporting safer procedures and improved outcomes.

“I am delighted to share my exceptional experience working with our partner on the development of our revolutionary cardiac interventional tool. The team’s professionalism, speed, and flexibility have been instrumental in bringing our medical device to fruition. What truly sets them apart is their dynamic and enthusiastic engineering team, whose passion and dedication have surpassed my expectations. Collaborating with them has not only been productive but also an inspiring journey, and I wholeheartedly recommend them as a trusted partner in the field of medical device innovation.” — Cardiologist & Assistant Professor of Medicine, Cardiovascular Startup

Industry

Cardiovascular Systems

Impact

  • Designed and developed the complete intracardiac visualization and intervention platform.
  • Built and assembled multiple prototype iterations.
  • Conducted in vitro testing at a leading European university and in vivo testing in collaboration with a U.S. institution.
  • Enabled the client to remain a lean startup focused on strategic growth and management.

Challenge

The client aimed to develop a novel intracardiac visualization and intervention platform that would allow for direct optical guidance during minimally invasive cardiac procedures. The solution needed to balance technological complexity with clinical usability, while ensuring safety and effectiveness in both lab and clinical settings.

Solution

As a contract developer and manufacturer, our team partnered with the client from concept through clinical validation. We:

  • Led the design and development of the entire device platform.
  • Assembled multiple prototype iterations to refine design and functionality.
  • Conducted in vitro testing with academic partners and supported in vivo testing with clinical collaborators.
  • Provided comprehensive development and engineering support, enabling the client to remain lean and focused on core startup priorities.
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