Simpson Interventions has announced that the Acolyte image-guided crossing and re-entry catheter system has been granted an investigational device exemption (IDE) by the US Food and Drug Administration (FDA), after having been designated as a breakthrough device last year. Additionally, the company also announced that its Shadow catheter has received 510(k) clearance from the FDA.
The Acolyte system is intended to facilitate revascularisation 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 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.
The Acolyte system received dreakthrough 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 enrol 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 commercialisation. 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 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. 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. Starling has held numerous roles at other notable Life Science companies throughout his career.
