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KOMISJA NADZORU FINANSOWEGO |
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Raport bieżący nr |
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2023 |
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Data sporządzenia: |
2023-02-27 |
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Skrócona nazwa emitenta |
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MILESTONE MEDICAL |
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Temat |
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The receipt of 510_k_ FDA clearance for the use of CompuFlo Epidural System in thoracic
indications
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Podstawa prawna |
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Art. 17 ust. 1 MAR - informacje poufne.
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Treść raportu: |
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The Board of Directors of Milestone Medical Inc. _WAR: MMD, "the Company", "the Issuer"_,
today announced that its CompuFlo Epidural System has received 510_k_ FDA clearance
for use in the thoracic region of the spine, including the cervical thoracic junction.
This approval expands upon the Company's prior approval of CompuFlo for use within
the lumbar region of the spine, where the focus has been on labor and delivery.
In the opinion of the Board of Directors the use of the CompuFlo Epidural System,
with its patented DPS Dynamic Pressure Sensing Technology in these newly expanded
indications, provides anesthesiologists and pain management providers the ability
to navigate challenging anatomical regions in the thoracic region and cervical thoracic
junction in real-time, confirming needle placement both audibly and visually, thereby
making the epidural procedure easier and safer to perform.
The Board of Directors of the Company believes this approval will be of benefit to
physicians who have been trained in the placement of epidurals in the thoracic and
cervical regions of the spine, including anesthesiologists and pain management providers
due to the difficulties accessing the epidural space, especially in the higher thoracic
cervical regions of the spine. The Board of Directors of the Company believes that
the use of the CompuFlo Epidural System in these regions will add another level of
safety, efficiency and confidence as it audibly and visually measures tissue pressures
in real time, allowing a provider to confirm the needle placement and will be a tremendous
assistance for spinal cord stimulator cases.
The CompuFlo device should also be beneficial in teaching residents and nurse anesthetists
the proper placement of epidural needles since it provides the instructor and student
audible and visual confirmation when the tip of the needle is in the correct location.
The Board of Directors of the Company is delighted to receive marketing clearance
from the FDA for this new thoracic indication and expand the scope of indications
beyond labor and delivery into challenging thoracic and cervical epidural procedures,
where the incidence rates of morbidity are believed to be much higher, at 17% and
30%, respectively. The FDA clearance represents a major milestone as it broadens the
market opportunity for CompuFlo Epidural System. The Board of Directors of the Company
looks forward to expanding the use of our technology within the area of pain management
and remain encouraged by the interest in our epidural instruments by anesthesiologists
and pain management providers, especially for patients with complex anatomy and difficult
cases that involve the thoracic and cervical thoracic junction.
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RB_ASO: The receipt of 510(k) FDA clearance for the use of CompuFlo Epidural System in thoracic
indications
