The Journal of the American Heart Association (JAHA) published an article in December saying that paclitaxel-coated balloons and stents manufactured by Boston Scientific and others had an increased risk of death.
The Journal of the American Heart Association (JAHA) published an article in December saying that paclitaxel-coated balloons and stents manufactured by Boston Scientific and others had an increased risk of death. In a January 17, 2019 letter to health care providers, the U.S. Food and Drug Administration (FDA) indicated it was evaluating available long-term follow-up data to determine if there were any long-term risks associated with the devices, but had drawn no conclusions as of yet.
Boston Scientific is defending their products, indicating it will work with the FDA. “Patient safety is our highest priority,” the company said in a statement to the Boston Business Journal. “We will continue to advance the clinical evidence of our (drug)-eluting technologies, and work in partnership with the FDA to reinforce safety and efficacy profiles.”
The device, Eluvia, launched last year for peripheral artery disease (PAD). It was approved by the FDA in September 2018. This is an illness where plaque accumulates in the arteries in the legs and decreases blood flow, which causes swelling, ulcers and possible limb amputation. According to Boston Scientific, it affects about 8.5 million people in the U.S.
The device is coated in or releases a chemotherapy drug, paclitaxel. The drug is used to prevent tissue from regrowing that might block the stented artery.
JAHA analyzed 28 different clinical trials and found that patients implanted with the devices had a mortality rate a year after surgery that was the same as patients who did not receive the devices. However, five years later, there was a 14.7 percent death rate compared to 8 percent in the placebo group.
Boston Scientific, in its defense, also raised the FDA’s statement that the benefits of the devices outweighed their risks.
One study, which lasted a year, found Eluvia to be safer and more effective a year after surgery compared to a competitive drug-coated product from Cook Medical, based in Bloomington, Indiana.
In its letter to physicians, the FDA recommended they continue to observe their patients who received the paclitaxel-coated balloons and paclitaxel-eluting stents, discuss the risks and benefits of all available treatments with their patients, and report any adverse or suspected adverse events related to the devices.
“The FDA is currently evaluating available long-term follow-up data to determine if there are any long-term risks associated with paclitaxel-coated products,” the FDA wrote. “This will include an evaluation of long-term follow-up data from studies that supported approval of paclitaxel-coated balloons or paclitaxel-eluting stents in the U.S. and other available data sets. This review will focus on causes of death, the paclitaxel dose delivered, and patient characteristics that may impact clinical outcomes. Additional statistical analyses will be performed to clarify the presence and magnitude of any long-term risks. We are working with manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents to better understand this issue.”
FDA also noted there were a number of such devices approved or being studied in the U.S. “Currently, the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications or use.”
