How Monteris Medical navigated a surgical robotics recall
"NeuroBlate uses a robot-guided laser to ablate brain tissue during MRI
scans. Some brain surgeons find NeuroBlate a useful surgical option for
certain epilepsy and brain cancer patients who don’t have many other
alternatives.
Marty Emerson became CEO of Monteris Medical
in July 2016. Within a month, the first report came in of a problem:
The probe tip of the Plymouth, Minn.-based company’s NeuroBlate
robot-assisted brain surgery device unintentionally heated up during the
MRI-assisted procedure.
That discovery would eventually turn into a recall designated as
Class I by U.S. Food and Drug Administration (FDA) – Emerson’s first in
his roughly 30 years in medtech. Understanding and solving the problem
would consume Emerson and dozens of Monteris employees over the next two
years.
...
Company officials quickly determined the problem involved a coated
metal thermocouple that helped measure temperature inside the probe. As
Emerson explained it, the connector from the back of the probe to the
system had sometimes moved too close to the bore of the MRI magnet,
picking up energy that was transmitted down the probe and heating the
tip.
The problem only occurred inside particular MRI systems running
specific scan types, leading the Monteris team to test more than 20
permutations and combinations from companies including Philips, Siemens
and GE.
In December 2016, as the company’s investigation progressed, another
probe tip-heating case surfaced; two more incidents occurred shortly
before Monteris alerted the FDA in September 2017. In one, a patient
died of a brain bleed a few days after the procedure, although it wasn’t
conclusive that the probe tip heating was responsible, according to the
FDA.
Emerson said that Monteris came to FDA with a thorough understanding
of the problem, data from testing the 20 MR equipment permutations,
updated instructions for use designed to mitigate the issue and a
product development plan to permanently resolve the problem.
Communication and transparency among the Monteris team, with the FDA
and with physicians were front-of-mind for Emerson during this process,
he told us, recalling a number of late nights when executives and
regulatory experts jointly edited responses to the FDA. An accountant by
training, he also tried to stay mindful of what he didn’t know.
...
Some regulatory experts said that although the company’s response to
the problem wasn’t perfect, it appears to be out of the woods. In
October 2018, Monteris won FDA clearance for a laser probe with
fiberoptic-controlled cooling for NeuroBlate. The fiberoptic part
replaced a metal thermocouple inside the laser probe, enabling Monteris
to lift MR scan restrictions. All patient-contacting components are now
non-metallic.
In late 2018, Monteris also announced that more than 2,000 patients
have been treated with NeuroBlate since its release in 2013; the company
also won reimbursement from Aetna and Anthem. Emerson is optimistic
that the roughly $10 million a year company – which had seen annual
revenue growth of 40% before 2018 – is set to grow again as it turns its
focus to sales and marketing."
Source: The Robot Report
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