Marketwired07.20.16
Milestone Scientific Inc., a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies, has filed its 510(k) application with the U.S. Food & Drug Administration (FDA) for marketing clearance of its epidural instrument and disposables in the United States.
As previously announced, the company completed its COMPASS Study (CompuFlo Assessment Study), a randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of the epidural space verification with the CompuFlo Epidural Computer Controlled System. The clinical trial for the epidural instrument reached an enrollment of 400 patients and consisted of two separate arms: (i) pain management; and (ii) labor and delivery. Both arms were compared against the current medical standards of care. The goal of the pivotal Investigational Device Exemption (IDE) clinical trial was to demonstrate the accuracy of the CompuFlo technology in identifying and confirming the epidural space location.
The company also announced plans to submit the final data from the COMPASS Study including the results of the labor and delivery arm to an industry journal for publication. Interim data from the pain management arm of the study was presented in the U.S. at the American Society of Regional Anesthesia and Pain Management, and American Pain Society annual meetings. Additional interim data from the pain management arm recently presented at the European Society of Anesthesiology annual meeting in London, England, on May 28-30th.
"We are pleased to submit our 510(k) application on the heels of completing our clinical trials in the United States," said Leonard Osser, CEO of Milestone Scientific. "Having completed these trials, we are now accelerating our efforts to enter into domestic and international distribution agreements in advance of FDA marketing clearance. It is important to note, this study was designed to support not only submission to the FDA, but also facilitate U.S. reimbursement submissions as well as worldwide marketing."
Milestone Scientific Inc. (MLSS) is a medical research and development company that designs and patents innovative injection technology. Milestone's computer-controlled systems make injections precise, efficient, and virtually painless. The company is based in Livingston, N.J.
As previously announced, the company completed its COMPASS Study (CompuFlo Assessment Study), a randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of the epidural space verification with the CompuFlo Epidural Computer Controlled System. The clinical trial for the epidural instrument reached an enrollment of 400 patients and consisted of two separate arms: (i) pain management; and (ii) labor and delivery. Both arms were compared against the current medical standards of care. The goal of the pivotal Investigational Device Exemption (IDE) clinical trial was to demonstrate the accuracy of the CompuFlo technology in identifying and confirming the epidural space location.
The company also announced plans to submit the final data from the COMPASS Study including the results of the labor and delivery arm to an industry journal for publication. Interim data from the pain management arm of the study was presented in the U.S. at the American Society of Regional Anesthesia and Pain Management, and American Pain Society annual meetings. Additional interim data from the pain management arm recently presented at the European Society of Anesthesiology annual meeting in London, England, on May 28-30th.
"We are pleased to submit our 510(k) application on the heels of completing our clinical trials in the United States," said Leonard Osser, CEO of Milestone Scientific. "Having completed these trials, we are now accelerating our efforts to enter into domestic and international distribution agreements in advance of FDA marketing clearance. It is important to note, this study was designed to support not only submission to the FDA, but also facilitate U.S. reimbursement submissions as well as worldwide marketing."
Milestone Scientific Inc. (MLSS) is a medical research and development company that designs and patents innovative injection technology. Milestone's computer-controlled systems make injections precise, efficient, and virtually painless. The company is based in Livingston, N.J.