CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company, specializing in cardiovascular interventional devices, today announced achievement of major development milestones. Its truly unique Acolyte™ Image-Guided Crossing and Re-Entry Catheter System has been granted an Investigational Device Exemption by the U.S. Food and Drug Administration (FDA), after having been designated as a Breakthrough Device earlier this year. Additionally, the company also announced that its Shadow Catheter™ has received 510(k) clearance from the FDA.
“Receiving IDE approval of the Acolyte™ System, which we believe is groundbreaking in helping physicians treat patients with CTO, was a tremendous accomplishment for Simpson Interventions”
The Acolyte™ System is intended to provide interventional cardiologists with a more reliable and predictable tool to facilitate revascularization of coronary chronic total occlusion (CTO). A significant percentage of all patients with coronary artery disease, whether managed medically or referred for bypass surgery, have CTOs. An investigational device exemption (IDE) allows a device to be used in a clinical study to collect safety and effectiveness data. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE prior to studies being initiated.i
The Acolyte™ System received Breakthrough Device Designation (BDD) from FDA and was accepted into the Total Product Life Cycle Advisory Program Pilot (TAP Pilot), both in March of 2024. Only devices granted BDD by the FDA are eligible to enroll in the TAP Pilot Program, which promotes frequent strategic communication between FDA and medical device sponsors.
Simpson Interventions has also received 510(k) clearance for its Shadow Catheter™, paving the way for its commercialization. The single-use/disposable Shadow Catheter™ is indicated for interventional cardiology procedures and intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral arterial vasculature. This access helps facilitate placement and exchange of guidewires and other interventional devices for use during procedures, permitting simultaneous use of two guidewires and/or to subsequently infuse or deliver diagnostic or therapeutic agents.
“Receiving IDE approval of the Acolyte™ System, which we believe is groundbreaking in helping physicians treat patients with CTO, was a tremendous accomplishment for Simpson Interventions,” said Dr. Joseph Knight, Chief Executive Officer of Simpson Interventions. “To additionally receive 510(k) clearance for our Shadow Catheter™, which not only helps with wire exchanges but also aids in accessing side branches, is further proof that our company continues to innovate in the arena of interventional cardiology with tools to help interventional cardiologists be more efficient and effective in treating their patients.”
Simpson Interventions also added William N. Starling to its Board of Directors, in October of 2024. Mr. Starling brings more than 46 years of medical device experience to the board, including acting as co-founder and managing director of Synergy Life Science Partners. He was also CEO of Synecor LLC, from 2000-2024, a business generator of new Life Science companies where he was a cofounder of several companies and oversaw the acquisition of some. Mr. Starling has held numerous roles at other notable Life Science companies throughout his career. For more information, please visit https://www.simpsonint.com/copy-of-executive-management.
For more information about Simpson Interventions and its innovative medical technologies, please visit www.simpsonint.com.
About Simpson Interventions:
Simpson Interventions is a leading medical technology company committed to addressing unmet clinical needs in cardiovascular diseases through technological innovations in visual-guidance, enhanced intelligence, and electromechanical automation for minimally invasive percutaneous intervention.
For more information: www.simpsonint.com
Contacts
Media Contact:
Steve Kelly
Simpson Interventions
Email: stevek@simpsonint.com
