Medical device company Cordis has secured FDA approval for its new Selution drug-coated balloon catheter, adding to its product line for heart care. The device is intended to treat previously treated narrowed vessels, offering an alternative approach to managing arterial conditions.
The Selution catheter is designed to deliver medication directly to a narrowed artery without leaving behind a permanent metal implant. It stands as the first and currently only balloon of its kind approved for use in the U.S. that utilizes sirolimus, a drug aimed at preventing the artery from re-narrowing after treatment.
This approach contrasts with traditional stents, which are permanent implants. Matthew Muscari, president of Cordis’ American operations, explained the difference, stating that once a stent is placed, "Once you put a stent in, you can never take it out." He further noted that the stent remains implanted in the patient for the duration of their life.
According to Muscari, when a stent is implanted, there is a risk of the artery re-narrowing, with up to a 5% chance within one year. This risk increases to 12% after five years and further to 18% after ten years. The Selution device aims to address these concerns by offering a non-permanent solution that mitigates the risk of re-narrowing.
While Cordis is headquartered in Miami Lakes, Florida, the company maintains a significant presence in Irvine. It operates four facilities here, spanning a total of 76,000 square feet. These Irvine locations are designated as the exclusive manufacturing sites for the new Selution drug-coated balloon catheter, making Irvine central to the production of this newly approved medical device.
In anticipation of increased demand following the FDA approval, Cordis is scaling up its operations and has begun the process of hiring 50 new employees in Irvine. These new positions are spread across engineering, research and development, and other essential roles. Cordis currently employs 325 people within its Irvine facilities.
Cordis was founded in 1957 by biomedical engineer Dr. William Murphy Jr., beginning operations from a garage in Miami Lakes, Florida. One of the company’s initial products was an early version of a pacemaker, establishing its early roots in medical innovation.
The company remained an independent entity for approximately 30 years before being acquired by Johnson & Johnson for $1.8 billion in 1996. During its time under Johnson & Johnson, Cordis launched the first successful drug-eluting stent, which was commercialized in 2004. Following this period, the company was purchased by Cardinal Health in 2015. More recently, in 2021, Cardinal Health sold Cordis to the private equity firm Hellman & Friedman, returning Cordis to its status as a standalone company. The company’s operations extend beyond the U.S., encompassing over 65 countries worldwide.
