BMC’s Contract Manufacturing Expertise Drives Clinical Success of Seclusion Catheter

•  Jul 25, 2025
• Danna Salazar
• Business

At BMC, we specialize in contract manufacturing for the medical device industry, partnering with innovators to transform early-stage concepts into market-ready solutions. Our work on the Seclusion catheter—a device designed to treat chronic venous insufficiency (CVI) caused by superficial vein reflux—highlights how our expertise in design-for-manufacturing, precision engineering, and scalable production drives success.

The catheter, which received FDA 510(k) clearance in March 2025, benefited from a series of manufacturing enhancements implemented by our team to ensure reliable, high-quality production. By leveraging our experience as a trusted CMO partner, we refined the design and assembly processes, enabling a smooth transition from prototype to commercial readiness.

Our role also extended into the clinical phase. A BMC project lead was present at the first-in-human clinical procedures at Ciudad de Salud Hospital in Panama City, Panama, where their hands-on support contributed to seamless device performance and outstanding patient outcomes.

With its dual-balloon technology, the Seclusion catheter provides targeted, nonthermal, and nontumescent ablation therapy, enhancing patient comfort and establishing a new standard of care for superficial vein treatment.

This milestone reinforces BMC’s position as a strategic contract manufacturing partner, capable of guiding medical innovations from concept to FDA-cleared devices. We congratulate the team behind this catheter on reaching this important achievement and are proud of the role we played in its path to clinical success.

1 Comment

Michel Kong

18 Hours Ago

Multifunctional, smart and interactive materials that replace the functions of these facilities can dramatically change the future of buildings, making them more efficient and sustainable.

Reply