The US Food and Drug Administration (FDA) has granted 510(k) clearance to Zenflow’s Spring Scope and Camera Control Unit (CCU), a single-use cystoscope.
This device is equipped with a 12 French working channel, which is over 80% larger than existing single-use models, and is expected to enhance visualisation for urologists while ensuring patient comfort during procedures.
Zenflow CEO Shreya Mehta said: “With advanced imaging, catheter flexibility, and a large working channel, the Spring Scope is a meaningful innovation in its own right, and a key enabler and differentiator for our forthcoming BPH therapy, the Zenflow Spring Implant and Delivery System.
“This progress reflects our commitment to bringing patient-focused innovation to urologists and their patients.”
According to Zenflow, flexible cystoscopy is a procedure integral to diagnosing and treating lower urinary tract conditions and is cited as the most frequently conducted office-based procedure by urologists.
The company noted that the Spring System, comprising the Spring Scope, Implant, and Delivery system, has been crafted to improve the patient experience for men suffering from benign prostatic hyperplasia (BPH) symptoms.
In addition, the company stated that the Spring Implant and Delivery System is still under investigation and not yet available for commercial sale.
Plainview Hospital urology chief and investigator of the Zenflow Spring System Bilal Chughtai said: “This new cystoscope technology delivers clear imaging while also allowing us to provide advanced diagnostics and therapeutics in the comfort of our office. It’s an exciting and much-anticipated innovation in the field.”
Earlier this year, Zenflow disclosed that its Spring System showcased sustained benefits three years after placement in individuals with BPH, as observed in the ZEST pilot studies.
According to the company, the device is setting up a new category of treatment called first-line interventional therapy to offer minimally invasive treatments with safety benefits and reversibility similar to medication.
