FDA Clears Centricity Vision's ZEPTOLink IOL Positioning System
Centricity Vision announced that the ZEPTOLink™ IOL Positioning System has received 510(k) clearance from the FDA. This innovative platform has been designed to seamlessly integrate the clinically proven ZEPTO precision pulse capsulotomy technology with any phacoemulsification system. The integration of the ZEPTO technology with the phaco system streamlines cataract surgery and saves time and space in the operating room.
The ZEPTO technology is the first and only device that creates an instantaneous capsulotomy with consistent, 360-degree IOL overlap, which allows for optimal lens positioning and improved surgical outcomes. With the integration of the ZEPTOLink platform, surgeons have complete control via the phaco foot pedal, ensuring the delivery of the same strong, consistent, centered capsulotomy.
Centricity Vision will be introducing the ZEPTOLink platform at the ASCRS Annual Meeting in San Diego. Demonstrations of the platform will be performed at the Centricity Vision booth #710.
ZEPTOLink uses suction and irrigation provided by the phaco system, enabling surgeons to fully control the ZEPTO handpiece apposition, suction, energy delivery, and release using the phaco foot pedal. Key features include:
● Seamless integration with any phacoemulsification system;
● Small ergonomic console that attaches to any phaco system;
● Modern touchscreen display with voice-supported functions;
● Dedicated ZEPTOLink handpiece for efficient set-up, priming, and operation by a single person all within the sterile field; and
● Clinically proven ZEPTO technology for precise, consistent, and centered capsulotomies with 360-degree IOL overlap.
Centricity Vision plans to introduce ZEPTOLink to the US market in a phased approach, with a broader commercial launch later this year.
“As a current user, I value the safety, precision, and consistency of a ZEPTO capsulotomy. Now with the phaco integration, ZEPTOLink offers greater workflow efficiency than ever before,” said Eric Donnenfeld, MD.
The creation of a well-formed, centered capsulotomy is considered one of the most challenging aspects of cataract surgery, and it is critical for effective IOL positioning and stability. ZEPTOLink uses 12 micro-pulses of energy within just 4 milliseconds, allowing surgeons to center the capsulotomy with 360-degree IOL overlap on the patient's visual axis, leading to improved outcomes, as evidenced by studies1-4.
“By improving IOL centration and operating room productivity, ZEPTOLink will benefit patients and practices alike,” said Centricity Vision president and CEO, Rob Thornhill. “We believe this streamlined surgical solution will help drive the future of automated refractive cataract surgery."
References
1. Thompson V, Holladay J, Sretavan D. Use of P1-P4 Purkinje reflections as a surrogate sign for intraoperative patient fixation. J Cataract Refract Surg. 2021 Dec 1;47(12):e60-e65. doi: 10.1097/j.jcrs.0000000000000805. PMID: 34486578.
2. Singh I. For IOL placement, location is key. Ophthalmol Times. 2020;45(11):1,19.
3. Ifantides C, Lee J, Rouweyha R, VitalM, Sretavan D. Precision pulse capsulotomy: performance metrics and utility In routine and complex cases. J Cataract Refract Surg. 2020;46(11):1522-1529.
4. Gundersen K, Potvin R. Clinical results after precision pulse capsulotomy. Clin Ophthalmol. 2020;14:4533-4540.
