Bring Innovation into your operating room.
The CataPulse® is CE Approved and is currently pending FDA Approval.
Advance Technology
Designed to remove cataracts in a novel and technologically advanced way by utilizing High Frequency Pulsed Vacuum, the CataPulse® gently dissects the cataract material at the tip of the handpiece. This recent advancement in cataract surgery manipulates vacuum to aspirate the cataract material gently and efficiently.
High Frequency Pulsed Vacuum
Optimized for the cataract surgeon who wants the best results for their patients, the CataPulse® offers an elegant solution to today’s growing cataract market.
How it Works:
The “pulse” is generated by interrupting the vacuum at a set interval of time, ranging from 450 pulses per minute to 800. At a preset vacuum value, the High Frequency Pulsed Vacuum activates and begins dissecting tissue. The effect is an isolated micro-impact between the cataract material and the tip of the cannula. The diagram below illustrates the concept of high frequency pulsed vacuum.
The Benefits:
Some key benefits of High Frequency Pulsed Vacuum include no frictional heat, no need for continuous flow, and superior vacuum control. By interrupting the vacuum, the potential for vacuum surge is reduced and the inward energy increases the ability to purchase the cataract material, which provides superior followability. The impact at the tip caused by the High Frequency Pulsed Vacuum rapidly dissects and aspirates the cataract material while maintaining low flow through the eye. The goal is to successfully remove the hardened lens while reducing endothelial cell loss and improve the overall effects cataract surgery has on the cornea.
Superior Quality and Efficiency
Our commitment to excellent patient outcomes is evident in the quality of our product. Every kit goes through rigorous testing to ensure the highest quality standards. Our reliable disposable kits eliminate the need to disassemble, clean, sterilize, and reassemble the handpiece. This makes the operating room more efficient.
Superior Quality and Efficiency
By using the CataPulse®, several steps associated with Phaco become eliminated. The CataPulse® Lens Removal Kit includes the Lens Removal Handpiece, Irrigation Handpiece, and Sterile Drape. All come preassembled and ready to use out of the box. Just attach a cannula of your choice and insert the Lens Removal Cassette and the system is ready to use. The diagram below illustrates the simplifying effect the CataPulse® has on OR operation during cataract procedures, which translates to a faster return on investment.
Clinical Benefits
The high frequency pulsed vacuum delivers true efficiency to optimize lens extraction with reduced endothelial cell loss and clearer corneas postoperatively when compared to traditional phaco.*
*For a summary of the clinical investigation used to achieve CE Approved, click on the link to read more.
A Summary of the CataPulse® Clinical Study Used to Achieve CE Approval
About the Investigator
Dr. Antonio Mendez Noble is the director of the Vision Mendez Institute. He and his staff have been operating for more than 25 years in the field of refractive surgery. His subspecialties include cornea, external disease, and refractive surgery. He is an expert in advanced techniques and regularly treats cataracts and performs LASIK and cornea transplantation.
Study Population
A wide variety of of subjects with different ages and grades of cataracts were recruited for this study. The average age of the treated subjects was 65 and ranged from 46 to 83 years of age. Of the 73 subjects enrolled, 28 were male and 45 were female. All subjects had visually symptomatic age-related cataracts ranging from Grade 1 through Grade 4, according to LOCS II.
Follow-Up
The 73 subjects of the study were scheduled to be evaluated at baseline, 1 day, 15 days, and 30 days post-op. All but two subjects were evaluated as scheduled. Two subjects missed the 15 day follow-up but were evaluated at baseline, 1 day, and 30 days. There were zero adverse events or complications throughout the study.
Results
In the postoperative examinations, all subjects had clear corneas the following day, with only 13 showing minor signs of edema on day 1 postop. All patients successfully achieved at least 20/40 uncorrected visual acuity, with 93% achieving 20/30 or better. The average endothelial cell loss at day 30 was 2.86% with a 1.22% standard deviation.
Conclusion
Using the CataPulse®, there is a significant reduction in endothelial cell loss when compared to the percentage loss of endothelial cells documented in studies* showing endothelial cell loss when ultrasound is used. Less endothelial cell loss means a greater long term health of the cornea, which corresponds to a higher quality of life and happier patients.