Headquartered in Grand Blanc, Michigan, Barron Precision Instruments, L.L.C. (BPI) is a privately owned company that has over 60 years of experience in the fabrication of sterile, disposable medical devices.
The Company currently focuses primarily on manufacturing quality instruments for use in the surgical treatment of diseases of the human eye. All of BPI?s products are intended for single use and are provided in hermetically sealed packages that have been sterilized with ethylene oxide at certified facilities.
BPI adheres to the ISO 13485 standard for comprehensive management of the design and manufacture of medical devices and is audited annually to verify compliance with that standard. The company has a certified clean room in which assembly and packaging of each device are done. All instruments are tracked by lot number, and records are kept that detail adherence to the documented procedures for fabrication of the devices.
BPI’s products are manufactured according to FDA Good Manufacturing Practices, and follow the strictest quality control procedures as specified in the ISO 13485 standard. The product line includes high-quality trephine blades, vacuum cornea trephines, donor cornea punches, and artificial anterior chambers. These products are sold through distributors in over 90 countries throughout the world.
BPI developed a proprietary multi-stage honing process that provides trephine blades with unsurpassed cutting edges. The blades are fabricated from the hardest high-carbon stainless steel available, and the perfect cylindrical diameters are controlled to within 6 microns (0.00025 inch).
The trephine blades come in 14 sizes ranging from 6 mm to 16 mm diameter, and each blade has the size etched into the side so there is no uncertainty when the surgeon is preparing to use it.
The two families of punches intended for penetrating keratoplasty come in 13 sizes from 6 mm to 9.5 mm diameter and utilize the same multiple stage honing technology that is used to fabricate the blades in the trephines. The Asymmetric punch uses a patented process for shaping the blade so that a small tail is provided for handling the tissue. It comes in one size, a 7.6mm main circle with a tail that extends 2.8mm.
Artificial Anterior Chamber
The Barron Artificial Anterior Chamber was developed to provide support for donor cornea tissue in a position with the epithelial surface up. The device simulates the anterior chamber of the eye by allowing fluid to support the cornea. Surgeons can use either a liquid such as viscoelastic or balanced salt solution (BSS), or a gas such as air. The dual ports allow a liquid to be injected through one port and air be injected through the other port to provide a compressive support system. The donor cornea can be cut with a vacuum trephine, thereby giving a good edge match with the trephinated patient cornea.
Vidaurri Fluid Retention Ring
The Vidaurri Fluid Retention Ring is a stainless steel vacuum cylinder that is designed to attach to the patient cornea to hold fluids for photorefractive keratectomy (PRK), corneal cross-linking, or any other procedure that requires a fluid to be constrained locally on the cornea. It is 8.7mm in diameter and attaches to a vacuum syringe.
Janke-Barron Heart Support
Although BPI focuses primarily on products associated with eye surgery, the company also manufactures the Janke-Barron Heart Support, which is designed to provide access to the posterior surface of the heart. Made of Dacron in a net-like configuration, it conforms to the shape of the heart while distributing pressure in a way that reduces the possibility of damage to the muscle. The Janke-Barron Heart Support is sold by Edwards Lifesciences as their product number 4800.