MILESTONE: strona spółki
27.02.2023, 21:01
MMD The receipt of 510(k) FDA clearance for the use of CompuFlo Epidural System in thoracic indications
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.
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.