US-based cardiovascular intervention devices maker Simpson Interventions has received the US Food and Drug Administration (FDA) 510(k) approval for its Shadow Catheter.
Simpson also received FDA’s Investigational Device Exemption (IDE) approval for its truly unique Acolyte Image-Guided Crossing and Re-Entry Catheter System.
The FDA IDE approval follows a Breakthrough Device designation granted earlier this year.
Also, the company announced the appointment of William Starling to the Board of Directors.
Starling has more than 46 years of experience in the medical device sector, including as co-founder and managing director of Synergy Life Science Partners.
Simpson Interventions CEO Joseph Knight said: “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.
“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.”
According to the medical device company, the FDA 510(k) approval will support the commercialisation of its Shadow Catheter.
Shadow Catheter is a single-use catheter indicated for interventional cardiology procedures.
Together with steerable guidewires, the catheter is intended for accessing distinct regions of the coronary and peripheral arterial vasculature.
Shadow facilitates the placement and exchange of guidewires and other interventional devices during procedures, enabling simultaneous use of two guidewires.
Simpson secured FDA Breakthrough Device Designation for Acolyte System and was accepted into the Total Product Life Cycle Advisory Program Pilot (TAP Pilot), in March 2024.
The Acolyte System is designed to provide interventional cardiologists with a more reliable and predictable tool to enable revascularisation of coronary chronic total occlusion (CTO).
According to the company, a significant percentage of all patients with coronary artery disease, who are managed medically or referred for bypass surgery, have CTOs.
The US FDA grants investigational device exemption (IDE) approval to allow the use of a device in a clinical study to collect safety and effectiveness data.
