Major medtech players Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) continue to support the use of their paclitaxel-eluting devices in the legs after a study released last month indicated a link between the devices and an increased mortality rate, according to a Star Tribune report.
In the meta-analysis, researchers led by Dr. Konstantinos Katsanos analyzed data from 28 trials involving paclitaxel-coated devices used in the femoral and/or popliteal artery. Data from the trial indicated a 68% relative increase in all-cause mortality risk with paclitaxel-coated devices after two years and a 93% relative increase after five years when compared to therapy with uncoated devices.
Results from the trial were published in the Journal of the American Heart Association in December.
Executives from both companies spoke at the J.P. Morgan Healthcare Conference in San Francisco suggesting that their own data does not support the higher death rates noted in the new study, according to the Star Tribune.
“We’ve generated a ton of clinical evidence: 1,800 patients, we have data out to five years, randomized controlled study for the U.S., randomized controlled clinical study for Japan, global registry data. And all of these data have been analyzed. We have not seen this safety signal in our data,” Medtronic cardiac and vascular group prez Mike Coyle said at the presentation, according to the report.
Boston Scientific global chief medical officer Ian Meredith commented on the meta-analysis, suggesting that studies of its kind can sometimes reach findings which don’t emerge in later studies, according to the Star Tribune. He also noted that the study did not identify a potential mechanism for the increased mortality rate.
“I think at this stage, good clinical studies are appropriate. There does not seem to be a plausible mechanism to understand how a dose that imperceptible in plasma or tissue at 30 days could actually really affect mortality two years and beyond,” Meredith said, according to the report.
Meredith also commented that paclitaxel has been in use for more than 20 years in oncology, where it is used in larger doses than are used in drug-eluting devices. Despite the increased volume, Meredith said, oncologists have found no similar increase in risk of death, according to the Star Tribune.
Study authors had a different take, suggesting that the paclitaxel used in chemotherapy by oncologists is solvent-based and only has a half-life of approximately six hours, where as the paclitaxel on devices has a half-life of weeks to months, according to the report.
The medical community isn’t likely to move away from using such devices immediately, suggests vascular surgeon Dr. David O’Connor, who argues that the theoretical heightened mortality does not outweigh risks including vessel closure and amputation that are associated with non drug-eluting device use, according to the Star Tribune.
“With the alternative of not using the drug-eluting technologies, the trade-off would be a higher incidence of the vessel re-blocking over time, which can lead to amputation, or a need for another procedure, or a more complicated procedure,” O’Connor told the paper.
While the medical device companies stand by their devices, Katsanos stands by the study results and suggests that they are too significant to ignore, according to the Star Tribune.
“I do understand the skepticism of the industry, but at the end of the day, the statistical signal is too strong to be ignored by reasonable doubt,” Katsanos told the paper.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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