Medical technology company Lensar has received the European Union’s (EU) Medical Device Regulation (MDR) certification for its ALLY Adaptive Cataract Treatment System.
Lensar focuses on designing, developing, and marketing advanced systems for cataract treatment and astigmatism management as part of the cataract procedure.
Its ALLY System is a compact and highly ergonomic device for laser cataract procedures. It features a rapid dual-pulse laser and integrates artificial intelligence (AI) with proprietary imaging and software.
It aims to improve cataract surgery using Lensar’s technologies, enabling procedures to be performed in a sterile operating room or in-office surgical suite.
The cataract treatment system secured US Food and Drug Administration (FDA) 510(k) clearance in June 2022.
According to Lensar, this flexibility enhances operational efficiency and reduces overhead.
The system also includes Lensar’s proprietary Streamline software technology, which helps surgeons achieve improved outcomes.
With the recent MDR certification, the medical technology company plans to introduce the technology to surgeons across the EU.
Lensar, a spin-off of PDL BioPharma, plans to roll out the ALLY System through its distributor network in the EU, with the first installations anticipated in Q3 2024.
The cataract treatment developer said that the system addresses the limitations of older, first-generation technologies and enhances operating room efficiency.
In recent time and motion studies, the device has saved significant time in procedures, leading to increased revenue opportunities for surgeons and ambulatory surgery centres, and reduced patient throughput time.
Lensar president and CEO Nick Curtis said: “We believe ALLY’s commercial availability in the EU creates a significant growth opportunity for us, through the ability to provide new capabilities and advanced next-generation laser technology to European surgeons.
“European cataract surgeons now have access to a technology that has demonstrated to not only enhance the precision, efficiency and patient satisfaction associated with the procedure, but also to significantly improve practice workflow and economics.”
ALLY is said to be the first cataract laser to incorporate AI for iris registration and surface identification in astigmatism management.
Additionally, the system automatically assesses cataract density, optimises fragmentation patterns and energy settings, aiming to reduce the total energy required for the procedure.
