Dune Medical is gearing up for an immediate U.S. launch of its MarginProbe breast cancer detection device now that an FDA advisory panel has recommened approval for the system.
Following a thumbs-up for its first-of-a-kind MarginProbe breast cancer detection device last week, Dune Medical Devices is promising to work closely with FDA to complete the approval process and plans an immediate U.S. launch should the watchdog agency give it a green light.
The FDA's general & plastic surgery devices committee met June 21 in Gaithersburg, Md., to mull whether the device, which uses electromagnetic waves to identify possibly cancerous tissue on the edges of a breast tumor, ought to be approved for the U.S. market.
The panel voted 11-0 that the device is safe, 8-1 with 2 abstentions that it is effective and 10-1 that its benefits outweigh its risks.
During a public hearing prior to the vote, speakers expressed unanimous support for approval of the MarginProbe device.
"We are very pleased with the panel's positive decision on the MarginProbe system for use in the U.S.," Dune CEO Dan Levangie said in prepared remarks. "We believe that the MarginProbe System will give surgeons a powerful tool in their fight against breast cancer and provide women a substantially better chance of avoiding additional surgeries."
The MarginProbe device, which won CE Mark approval in the European Union in 2006, is Framingham, Mass.-based Dune Medical's first commercial product.
The company submitted a pre-market approval application in April 2011, based on data from a 600-patient pivotal study conducted primarily in the U.S.
The company cites studies showing that the device's detection of "positive margins" – the cancer found at the edges of excised breast tissue – contributes to a 50% reduction in additional procedures to remove residual cancer.
The data show that "between 30%-60% of women who undergo breast conservation surgery have to undergo additional surgeries because doctors fail to achieve negative margins during the first surgery," according to Dune Medical.