The FDA has granted Centricity Vision Inc. 510(k) clearance for its ZEPTOLink intraocular (IOL) Positioning System, designed to streamline cataract surgery via merging the company’s precision pulse capsulotomy (PPC) technology (ZEPTO) with any phacoemulsification (phaco) system.
Talk about this technology.
As the first and only device of its kind, the ZEPTO system applies 12 micro-pulses of energy in 4 milliseconds to produce instantaneous capsulotomy for an exact 360° IOL overlap on a patient’s visual axis.
The results are potentially improved, long-term visual outcomes for patients.
How does it work?
The system uses a phaco system’s suction and irrigation to give surgeons full control over the handpiece, suction, and energy delivery.
Three steps are included:
- Insertion of the hand tip via a 2.2+ mm incision.
- Suction delivery of the centered handpiece tip close to the lens capsule.
- Application of energy micropulses (forming the capsulotomy) and removal of the device through the main incision.
See here for a visual step-by-step walkthrough.
Give me some feature details.
Included in the system is a modern touchscreen display with voice-supported functions and a dedicated ZEPTOLink handpiece—with two nitinol ring size options—for efficient set-up, priming, and operation by one clinician.
What makes it unique?
By integrating with any phaco system, ZEPTO takes up minimal space in the operating room—while possibly saving time—as well as provides surgeons with complete control (via a phaco foot pedal) to deliver precise and strong capsulotomies for effective lens positioning.
What kind of chamber depth can be used?
Centricity Vision recommends a chamber depth of 2.5 to 3.75 mm for first cases; however, a surgeon may choose a more posterior location for the primary incision and minimize ophthalmic viscosurgical device (OVD) use to compensate for a deeper chamber.
Can it be reused?
Nope, the disposable handpiece is intended for one-time use only.
Are pediatric capsulotomies permissible with it?
According to the company, pediatric capsulotomies are currently contraindicated.
When can I try it out?
Centricity Vision is planning to start with a phased approach for a US-market roll out followed by a broader commercial launch later in 2023.
In the meantime, the company is planning to unveil the product at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in San Diego, May 5-8, 2023.