Medical Design Briefs - March 2024 - 15

known in other devices, and expert guidance
is needed to advance development
of these systems without encountering
pitfalls.
Clinically, significant investigation is
ongoing regarding the most optimal
catheter designs, electric field prescriptions
(waveforms and parameters), and
pulse-delivery algorithms. Unlike thermal
modalities (where tissue temperature
is readily measured and directly
correlated to clinical effects), electric
field therapy's efficacy cannot be directly
or immediately measured in situ. This
gives rise to another challenge, which is
that every clinical indication, every PFA
system, and every configuration permutation
of a given system requires some
level of clinical evidence to assess performance
and safety. Being a new technology,
and with substantial " unknowns "
in the basic science, the concept of " substantially
equivalent " will be a challenge
to define.
Overcoming these development hurdles
will require deep knowledge of the
technical, regulatory, and clinical challenges,
ideally from a partner who has
solved these problems before.
Future Outlook
There is no doubt that the tissue selectivity
benefits of PFA are likely to be the
leading cause of its widespread adoption
in cardiac electrophysiology in the very
near future. And, as PFA technology matures,
it is also likely to provide clinical
benefits in the treatment of other diseases
and therapies. The flurry of investments,
development work, clinical trials,
and marketing of this technology will
benefit those companies that are most
knowledgeable in the space, understand
the technology from a first-principles
level, execute product development with
an appreciation of the unique challenges
of this technology, and can navigate
the complex interactions between disparate
system components.
Developing a PFA Partnership
A design, development, and manufacturing
partner to the medical device
industry is crucial. Minnetronix Medical,
for example, has a specialization in surgical
energy devices: devices (such as RF and
PFA generators), which deliver electrical
energy to tissue. Its ~500 employees (of
which 200 are degreed engineers and
scientists) solve complex medical device
challenges, currently with more than 40
active development projects. The team
manufactures more than 25,000 finished
medical devices annually, ranging from
small wearable sensors to refrigeratorsized
equipment consoles. The Minnetronix
surgical energy team has developed
more than 30 RF and PFA generators for
clinical applications, including electrophysiology,
oncology, denervation, and
other indications across the entire human
body.
This article was written by Dan
Friedrichs, PhD, who leads development
engineering efforts, and Aaron McCabe,
PhD, who is technology segment director
focused on surgical energy applications
at Minnetronix Medical, St. Paul,
MN. For more information, e-mail
dfriedrichs@minnetronixmedical.com
or visit www.minnetronixmedical.com.
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Medical Design Briefs - March 2024

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