MILESTONE: strona spółki
13.05.2020, 20:34
MMD Publication of Study Validating Efficacy of CompuFlo CathCheck System to Confirm and Monitor the Placement of an Epidural Catheter
The Board of Directors of Milestone Medical Inc. (WAR: MMD, “the Company”, “the Issuer”) today announced the publication of a study in the Open Journal of Anesthesiology, in an article entitled, "Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the Compuflo® Cath-Checker System," reinforcing the efficacy of the CompuFlo® CathCheck™ System to confirm the correct placement and positioning of an epidural catheter for use during and after an epidural procedure.
For the purposes of this study, the CompuFlo Epidural System utilized the new CathCheck™ technology to combine both objective in-line pressure measurements and detection of a pulsatile pressure waveform in a single system. This prospective, open trial is the first study to investigate the capability of the CompuFlo® CathCheck™ System to detect the pulsatile waveform confirming the correct placement of an epidural catheter, which provides an important metric in seconds to a healthcare worker in order to determine if a catheter is functioning properly or not. The current standard-of-care lacks such an objective means when making this determination and relies primarily on the administration of a medication through the catheter and then waiting 20 to 40 minutes for a patient’s response to determine if that catheter is dysfunctional or not. In contrast, the CathCheck™ system provides the important information in real-time to make the appropriate determination, allowing greater efficiency and improved patient care. The study received formal approval from the Institutional Ethics Committee of Lazio 1 in Roma, Italy. The study was performed on 30 epidural catheters previously used for post cesarean analgesia and about to be removed. All the patients were given 5 mL 2% lidocaine to test the catheter before its removal. After priming with 5 mL saline, the catheter was connected to CompuFlo® CathCheck™ System to record the occurrence of pulsatile waveforms or their disappearance during its removal. Pulsatile waveforms (originating from the spinal cord and transmitted through the dura in synchrony with heart rate) were observed in all the catheters properly located in the epidural space and disappeared when the catheter was extracted from the epidural space. The pulsatile pressure waveform analysis through the epidural catheter resulted in a sensitivity of 100%, a positive predictive value of 100%, a specificity of 100% and a negative predictive value of 100%. The Board of Director of the Company is honored to have the results of this study featured in this journal with its global audience of anesthesiologists. The findings of this open trial further validate the ability of the CompuFlo® CathCheck™ System to safely and accurately identify location of the needle or catheter in the epidural space. Publications such as these serve to highlight the benefits of our technology, which should help drive broad adoption among leading anesthesia providers around the world. The unique computer-controlled real-time pressure sensing technology combined with pulsatile pressure waveform measurement has the potential to transform the administration of epidural procedures and subsequent monitoring of catheter placement following an epidural procedure by confirming the placement of a catheter within seconds, versus 20–40 minutes using conventional methods. The Board of Director of the Company believes the CathCheck™ feature will help to significantly reduce time and cost for the institution by providing a more reliable way to re-check the catheter throughout the day to ensure that the catheter has not been displaced. Study investigators include, Giorgio Capogna, Michela Camorcia, Cristiana Berritta, Mark Hochman and Matteo Velardo from EESOA Maternal Neonatal Simulation Center, Roma, Italy and Cittàdi Roma Hospital, Roma, Italy. Dr. Capogna is MD, Head of the Department of Anesthesiology at Città di Roma Hospital in Rome and a Member of Milestone Scientific’s Scientific Advisory Board. Mark Hochman is D.D.S, Director of Clinical Affairs for Milestone Scientific Inc., the licensor of the Company’s computer-controlled injection and drug delivery technology.
For the purposes of this study, the CompuFlo Epidural System utilized the new CathCheck™ technology to combine both objective in-line pressure measurements and detection of a pulsatile pressure waveform in a single system. This prospective, open trial is the first study to investigate the capability of the CompuFlo® CathCheck™ System to detect the pulsatile waveform confirming the correct placement of an epidural catheter, which provides an important metric in seconds to a healthcare worker in order to determine if a catheter is functioning properly or not. The current standard-of-care lacks such an objective means when making this determination and relies primarily on the administration of a medication through the catheter and then waiting 20 to 40 minutes for a patient’s response to determine if that catheter is dysfunctional or not. In contrast, the CathCheck™ system provides the important information in real-time to make the appropriate determination, allowing greater efficiency and improved patient care. The study received formal approval from the Institutional Ethics Committee of Lazio 1 in Roma, Italy. The study was performed on 30 epidural catheters previously used for post cesarean analgesia and about to be removed. All the patients were given 5 mL 2% lidocaine to test the catheter before its removal. After priming with 5 mL saline, the catheter was connected to CompuFlo® CathCheck™ System to record the occurrence of pulsatile waveforms or their disappearance during its removal. Pulsatile waveforms (originating from the spinal cord and transmitted through the dura in synchrony with heart rate) were observed in all the catheters properly located in the epidural space and disappeared when the catheter was extracted from the epidural space. The pulsatile pressure waveform analysis through the epidural catheter resulted in a sensitivity of 100%, a positive predictive value of 100%, a specificity of 100% and a negative predictive value of 100%. The Board of Director of the Company is honored to have the results of this study featured in this journal with its global audience of anesthesiologists. The findings of this open trial further validate the ability of the CompuFlo® CathCheck™ System to safely and accurately identify location of the needle or catheter in the epidural space. Publications such as these serve to highlight the benefits of our technology, which should help drive broad adoption among leading anesthesia providers around the world. The unique computer-controlled real-time pressure sensing technology combined with pulsatile pressure waveform measurement has the potential to transform the administration of epidural procedures and subsequent monitoring of catheter placement following an epidural procedure by confirming the placement of a catheter within seconds, versus 20–40 minutes using conventional methods. The Board of Director of the Company believes the CathCheck™ feature will help to significantly reduce time and cost for the institution by providing a more reliable way to re-check the catheter throughout the day to ensure that the catheter has not been displaced. Study investigators include, Giorgio Capogna, Michela Camorcia, Cristiana Berritta, Mark Hochman and Matteo Velardo from EESOA Maternal Neonatal Simulation Center, Roma, Italy and Cittàdi Roma Hospital, Roma, Italy. Dr. Capogna is MD, Head of the Department of Anesthesiology at Città di Roma Hospital in Rome and a Member of Milestone Scientific’s Scientific Advisory Board. Mark Hochman is D.D.S, Director of Clinical Affairs for Milestone Scientific Inc., the licensor of the Company’s computer-controlled injection and drug delivery technology.