Health care supply company BD is shutting down its Lutonix drug-coated balloon facility in New Hope next year, following company consolidation plans and an industrywide decline in the use of certain drug-eluting devices for the legs.
The decision to shut down the Lutonix "technology center" at 9409 Science Center Drive will cause the elimination of 53 of the center's 85 positions, with the remaining positions either relocated to Tempe, Ariz., or offered through telecommuting, a BD statement said.
All affected employees are eligible for severance benefits and are getting a minimum notice period of two months, providing time to pursue jobs in BD or at other companies. A notice from the Minnesota Department of Employment and Economic Development said the cuts affect jobs in research and development, engineering, accounting, regulatory affairs, quality control and other areas.
"After a comprehensive and careful analysis of our Lutonix drug-coated balloon operations, BD has made the difficult decision to close its Lutonix technology center … effective March 31, 2020," a BD company statement said. "This site closure results from a strategic decision, as part of our 2020 business planning efforts, to consolidate functions at the New Hope facility with the rest of our Peripheral Interventions business."
Lutonix was originally a venture-backed Minnesota med-tech company that developed a medical balloon for use on blocked blood vessels above the knee, known as peripheral artery disease (PAD). When temporarily inflated inside the blood vessel, the balloon coats the inside of vessel wall with the anti-inflammation drug paclitaxel, which has been shown to keep vessels open more reliably than the same procedure without the drug.
This year, the U.S. Food and Drug Administration cautioned doctors that it had confirmed a report that patients who had drug-coated balloons and stents used in the legs above the knee were dying at higher rates after five years than people who were treated without the drug. The FDA is now working with the makers of paclitaxel devices for the upper legs to add disclaimers to product labels, while also gathering more clinical data to illuminate the still unexplained trend.
The FDA does not recommend doctors completely avoid the devices — patients at higher risks for vessel reclosure and repeat procedures may still find the benefits outweigh the risks.
In August, the FDA also denied BD's application for premarket approval (PMA) to sell the Lutonix device to treat blockages below the knee, which trade publication MD+DI said was likely related to the scrutiny of paclitaxel use above the knee.