Client Background

An early-stage company based in Southern California developed a powerful new minimally invasive technology for heart valve replacement.

Client Challenge

This company needed an FDA registered, ISO 13485 certified contract manufacturer to assist with the assembly and packaging of their endovascular system.

LSO’s Role

LSO provided the company with process and development guidance and a range of services including ordering and inspection of raw materials, ultrasonic cleaning, final assembly, and labelling development for primary and secondary packaging.

Client Results

This novel technology proved to be a clinical success by providing the patient with dramatically shorter recovery time, as compared to traditional open heart procedures. This cardiovascular company was acquired by a multinational company in 2008.