Ra Medical Systems reports progress with extending DABRA catheter shelf life

Earlier, Ra Medical Systems reported progress with extending the shelf life of its "more robust, next generation" DABRA catheter, featuring a braided overjacket to improve deliverability when navigating tortuous anatomy. The company also announced completion of "all 116 items identified in a quality improvement plan that stemmed from an internal audit in late 2019, with enhancements to standard operating procedures, preventive maintenance, equipment status, and calibrations and supplier quality." Initial accelerated aging testing supports shelf life of six months or longer on the next generation DABRA catheter, said the company, noting that this follows the company's previously disclosed identification of the two primary issues related to the catheter's limited shelf life as being the introduction of unwanted elements into its core water and the degradation of its inner coating. Ra Medical expects to complete the engineering work for this catheter, including expanded testing currently underway to further support the catheter's longer shelf life, by approximately mid-2021 and subsequently submit to the FDA for clearance. "While we continue to conduct additional real time and accelerated aging shelf life studies with the next generation catheter, we are thrilled with the results thus far, which we believe show we have identified and mitigated the principal causes of the previous shelf life limitations. I am also pleased with the completion of the quality improvement plan, which required tremendous effort by my colleagues and reflects our dedication to ensuring we have a robust and effective quality system," said Will McGuire, Ra Medical Systems CEO.