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KOMISJA NADZORU FINANSOWEGO |
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Raport bieżący nr |
7 |
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2017 |
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Data sporządzenia: |
2017-06-12 |
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Skrócona nazwa emitenta |
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MILESTONE MEDICAL |
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Temat |
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Receiving 510_k_ FDA Clearance for CompuFlo® Epidural Instrument |
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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 the CompuFlo® Epidural Computer Controlled Anesthesia System has received
510_k_ clearance from the U.S. Food and Drug Administration _FDA_. The CompuFlo® Epidural
System provides anesthesiologists and other Health Care Providers for the first time,
the ability to quantitatively determine and document the pressure at the needle tip
in real-time. The CompuFlo® Epidural's proprietary DPS Dynamic Pressure Sensing Technology™
_DPS_ allows the CompuFlo® Epidural to provide objective visual and audible in-tissue
pressure feedback that allows anesthesiologists to identify the epidural space.
The Board of Directors of Issuer is pleased to receive marketing clearance from the
FDA, which is considered globally to be the regulatory gold standard in premarket
review.
Looking ahead, the Company is now focused on reaching out to the top key opinion leaders
in the U.S., as the Issuer has been doing successfully across Europe. The CompuFlo®
Epidural System's ease of use allows use by medical professionals with varying levels
of experience, which further drives the value proposition of this technology. In addition,
due to what is seen as the device's add-on value proposition, the Company plans to
seek reimbursement codes over and above those already in place for traditional epidural
procedures.
510_k_ FDA Clearance was supported by the COMPASS Study _CompuFlo® Assessment Study_,
which was a prospective, randomized, controlled, parallel group, multicenter, pivotal
study to assess the safety and effectiveness of epidural space verification with the
CompuFlo® Epidural Instrument. The primary objective of the COMPASS study was to determine
whether the success rate of performance of lumbar epidural anesthesia with the CompuFlo
Epidural to identify the epidural space is equivalent to performance of lumbar epidural
anesthesia with the LOR technique. The clinical study enrolled 400 patients, of which
two-hundred-forty subjects _240_ required epidural procedure as part of the chronic
pain management and one-hundred-sixty _160_ required epidural procedure for acute
pain management during labor and delivery. The CompuFlo® Epidural with Dynamic Pressure
Sensing Technology resulted in the anesthesiologists objectively identifying the epidural
space with 99% success on the first attempt. The COMPASS study involved use of the
CompuFlo Epidural in 21 obese subjects _BMI > 31_, with performance in this group
found to be comparable to the performance seen in patients with lower BMIs. However
due to the relatively small sample size of obese patients studied, the safety and
effectiveness profile in this subgroup of patients is not fully known.
Based on the nonclinical and clinical tests conducted, it was demonstrated that the
CompuFlo Epidural device is as safe, as effective and performs as well as or better
than the legally marketed predicate devices.
The overall results of the COMPASS study demonstrated that the CompuFlo® Epidural
can serve as an everyday epidural needle placement confirmation solution.
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RB_ASO: Receiving 510(k) FDA Clearance for CompuFlo® Epidural Instrument 
