Zenflow Receives FDA 510(k) Clearance for First Single-Use Cystoscope with Largest Working Channel
核心洞察
Zenflow (搜索)'s Spring Scope (搜索) becomes the first single-use cystoscope of its kind to receive FDA 510(k) clearance, featuring a 12 French working channel that is more than 80% larger than current single-use models.
The device enables improved visualization during flexible cystoscopy procedures while maintaining patient comfort, addressing a critical need in the 1.2 million annual cystoscopies performed in the United States.
The clearance supports Zenflow (搜索)'s broader Spring System platform, which includes an investigational BPH (搜索) implant currently being evaluated in the pivotal BREEZE trial with over 200 participants.
The FDA has granted 510(k) clearance to Zenflow (搜索)'s Spring Scope (搜索) & Camera Control Unit, marking the first single-use cystoscope of its kind to receive regulatory approval. The device features a 12 French working channel, which is more than 80% larger than current single-use models, enabling improved visualization during flexible cystoscopy procedures.
Device Innovation and Clinical Impact
The Zenflow (搜索) Spring Scope (搜索) addresses a significant clinical need in urology, where flexible cystoscopy represents the most common office-based procedure performed by urologists. In the United States alone, approximately 1.2 million cystoscopies are performed annually, making this technology essential for diagnosing and treating lower urinary tract conditions.
"This new cystoscope technology delivers clear imaging while also allowing us to provide advanced diagnostics and therapeutics in the comfort of our office," said Bilal I. Chughtai, MD, chief of urology at Plainview Hospital (搜索) in New York. "It's an exciting and much-anticipated innovation in the field."
Broader Platform Development
The Spring Scope (搜索) serves as a key component of Zenflow (搜索)'s broader Spring System platform, which also includes the investigational Spring Implant (搜索) and Delivery system for treating benign prostatic hyperplasia (搜索) (BPH (搜索)). While the implant system is not currently FDA approved, it has demonstrated promising results in clinical trials.
Clinical Trial Results
The Zenflow (搜索) Spring System has been evaluated in the ZEST pilot studies across patients with BPH (搜索). Data presented at the 2025 American Urological Association Annual Meeting included results from three clinical trials conducted across four countries: Mexico, Australia, New Zealand, and Canada.
The long-term data showed significant clinical benefits at three years following device placement. Patients demonstrated a 46% improvement in International Prostate Symptom Score (IPSS) from baseline to 36 months, with scores improving from 22.0 to 11.8. Quality-of-life scores, which measure the negative impact of BPH (搜索) symptoms, improved from 4.49 at baseline to 2.23 at the 36-month timepoint.
Importantly, the studies showed no negative impact on erectile or ejaculatory function through 36 months of follow-up.
Ongoing Clinical Development
Building on the ZEST studies, the device is currently under investigation in the pivotal BREEZE trial (NCT04987138), a prospective, randomized study that has enrolled over 200 participants through clinical trial sites in the US and Canada. Patients are randomly assigned 2:1 to receive the Zenflow (搜索) device or a sham procedure, with trial completion expected in June 2026.
"We're thrilled to receive FDA clearance for Zenflow (搜索)'s first product," said Shreya Mehta, CEO of Zenflow. "With advanced imaging, catheter flexibility, and a large working channel, the Spring Scope (搜索) is a meaningful innovation in its own right, and a key enabler and differentiator for our forthcoming BPH (搜索) therapy, the Zenflow Spring Implant (搜索) and Delivery System."