Global manufacturer Oertli Instrumente AG has received FDA 510(k) clearance for its Faros anterior cataract surgery system.
First up: a company refresh.
Founded in 1955 and based in Berneck, Switzerland, the ophthalmic medical equipment supplier is the manufacturer of its ocular surgery-based surgical platforms and instruments.
Zeroing in on these surgical platforms, the company’s lineup already includes:
- CataRhex 3
- FDA 510(k) cleared
- Compact and portable surgical platform for cataract and glaucoma surgery
- FDA 510(k) cleared
- OS 4
- Not FDA cleared (approved European Union Medical Device Regulation [EU MDR])
- Surgical platform designed for safer, easier, and more efficient ophthalmic surgery with a 3-pump system, SPEEP pump, and power light-emitting diode (LED) technology
- See details on the platform’s updated version
- Surgical platform designed for safer, easier, and more efficient ophthalmic surgery with a 3-pump system, SPEEP pump, and power light-emitting diode (LED) technology
- Not FDA cleared (approved European Union Medical Device Regulation [EU MDR])
Now this product.
The Faros anterior cataract surgery system is available as an anterior segment device or as a combined system for both anterior and posterior segments.
Specific surgical indications: cataract, vitreoretinal, and glaucoma
- Its features:
- Compact design
- For minimal space in operating rooms
- Rapid operational readiness
- Readiness time reported at under 1 minute
- Compact design
Note: This clearance is reported to include “all consumables for cataract surgery and emergency vitrectomy, ensuring that surgeons have access to a complete set of tools for eye care.”
Let’s talk about the unique components.
The platform includes a SPEEP pump that operates with the same concept as a peristaltic pump (a positive displacement pump for a wider variety of fluids) to independently control both vacuum and flow via a dual-linear foot pedal.
- Intended result: Precise, manual control of dosable holdability—regardless of tissue type—that’s generated right at the instrument opening
And the technology?
Oertli’s proprietary easyPhaco technology, developed for phacoemulsification, incorporates a fluidics concept that enables direct control over fragments (via a handpiece with a shortened cable length) as well as a high holdability.
Benefits for surgeons (visuals viewable here):
- Ultrasound (U/S) energy absorbed by occluded fragments
- Smooth fragment aspiration with no clogging
- Stable anterior chamber
- Available from 1.6 to 3.2 mm incisions
What about for MIGS?
When used for microinvasive glaucoma surgeries (MIGS), the platform uses High-Frequency Deep Sclerotomy (HFDS).
How it works: A surgeon inserts the HFDS glaucoma tip through a 1.2-mm paracentesis, placing six small sclerotomy pockets in the iridocorneal angle via a high-frequency diathermy delivery process.
What it offers: Direct access from the anterior chamber to Schlemm’s canal and on into the sclera, significantly reducing the outflow resistance of the trabecular meshwork (TM).
- The benefits: HFDS is noted as having a low rate of complications and promising long-term results—including with a shorter procedure.
And how does the system maintain IOP?
The Faros’s infusion system utilizes two options for sustaining intraocular pressure (IOP) and, as a result, ensuring a stable anterior chamber and eye:
- Active infusion
- Available on the Faros and OS 4 systems
- Gas-driven
- Reacts quickly to reach a pressure of up to 120 mmHg
- Independent of room height (due to fixed height of bottle)
- Available on the Faros and OS 4 systems
- Gravity infusion
- Available on the Faros, CataRhex 3, and OS 4 systems
- Mechanically-driven (Faros and OS 4 only)
- Maintains pressure at up to 100 mmHg or 135 cm (setting values selected directly on the surgical device)
- Dependent on height of a patient’s eye above the floor
- Available on the Faros, CataRhex 3, and OS 4 systems
Anything else?
Yes! A Power LED light source provides a light output reported to be up to 45% greater than previous device generations, Oertli noted.
The low setting options are designed to minimize phototoxic exposure to patients, while a wide controle range at low lumens is intended to be an “ideal combination with a 3D microscope.”