GISH BIOMEDICAL INC
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The company designs, manufactures, and markets disposable medical devices for various surgical specialties including cardiovascular surgery, orthopedics, and oncology. It was incorporated in 1976 and conducts its business from its registered head office located in Rancho Santa Margarita, California, United States.
The company’s products are single use disposable products or have a disposable component. Its principal products include oxygenators and oxygenator systems, blood reservoirs, cardioplegia delivery systems, custom cardiovascular tubing systems, central venous access catheters and ports, and blood recovery devices for post-operative use in orthopedic surgeries. The company’s product portfolio also includes targeted solutions for vascular access and orthopedics.
With a manufacturing facility and offices in Rancho Santa Margarita, California, the company markets its products worldwide through a combination of direct sales representatives and specialty medical distributors.
Gish Biomedical, Inc. develops and markets its devices for various applications within the medical community. The Company manufactures medical devices, which are marketed through direct sales representatives and distributors domestically and through international distributors. All of Gish’s products are single-use, disposable products or have a disposable component. The Company’s primary markets include products for use in cardiac surgery, myocardial management, infusion therapy and postoperative blood salvage. Products include cardiovascular tubing systems, arterial filters, cardiotomy reservoirs, the Vision oxygenator, venous reservoirs, the CAPVRF44, cardioplegia delivery systems, oxygen saturation monitors, critical care central venous access catheters and ports and the Orthofuser.
Description and history
Gish Biomedical, Inc., incorporated in 1976, develops and markets its devices for various applications within the medical community. The Company manufactures medical devices, which are marketed through direct sales representatives and distributors domestically and through international distributors. All of Gish’s products are single-use, disposable products or have a disposable component. The Company’s primary markets include products for use in cardiac surgery, myocardial management, infusion therapy and postoperative blood salvage. Products include cardiovascular tubing systems, arterial filters, cardiotomy reservoirs, the Vision oxygenator, venous reservoirs, the CAPVRF44, cardioplegia delivery systems, oxygen saturation monitors, critical care central venous access catheters and ports and the Orthofuser.
Custom Cardiovascular Tubing Systems
The Company produces custom tubing sets using clear Mediflex tubing. Such components are assembled in the Gish clean room, sterilized and then shipped either to the hospital or to one of the Company’s specialty distributors that service such hospitals. Gish also assembles custom tubing sets for several competitive medical device manufacturers under private-label agreements.
Gish introduced its first arterial filters in 1985. The Company’s first design contained a safety bypass loop incorporated into the filter housing. The Company received Food and Drug Administration (FDA) approval to market an improved design that became available for sale during the second quarter of fiscal 1994.
The Company’s cardiotomy reservoir systems consist of a polycarbonate reservoir, defoaming and filtration cartridge and mounting bracket. This enables the perfusion team to recover high volumes of shed blood, then defoam and filter it prior to returning it to the patient’s circulatory system. In addition to the cardiotomy reservoirs’ use in the operating room, Gish has developed several systems that allow the cardiotomy reservoir to be used as a pleural drainage or autotransfusion system during recovery.
As a life-sustaining device used during open-heart surgery, the oxygenator is a key component of the bypass circuit. Vision is assembled in Gish’s clean room using equipment and biocompatible materials, and then each unit is leak tested before shipment. Vision’s gas transfer performance is dependable and capable of maintaining the oxygen demands of patients of all sizes for periods of up to six hours. Vision’s air separation channel utilizes an arterial outlet pressure gradient and the natural buoyancy of air to minimize the passage of gaseous emboli towards the patient. The Company’s Vision oxygenator was sold in selected accounts both domestically and internationally for the first half of fiscal 1998. Gish made its full market release of this product for sale in January 1998.
A venous reservoir is a device used to pool, filter and defoam blood prior to its introduction to the oxygenator. Gish offers a variety of venous reservoirs, including some which incorporate the capacity for autologous transfusion post surgically. The Company also has several products that incorporate the functions of cardiotomy, venous reservoir, post surgical blood collection and blood reinfusion devices.
Gish’s CAPVRF44 hardshell venous reservoir combines a 360-degree rotational, top-entry 1/2-inch inlet for unrestricted venous drainage and a high-performance cardiotomy compartment with six sucker inlet ports to handle all of the blood coming from the surgical field. The CAPVRF44 is a perioperative device, capable of operating in both the
Cardioplegia Delivery Systems
The Company has developed a complete line of cardioplegia delivery systems, including a new cardioplegia device, for which it, on April 10, 2002, was granted clearance by the FDA to sell in the United States. The new cardioplegia device is CE-marked, allowing sale in Europe. Multiple systems are required for this technique due to varying physician preferences.
Gish’s original offerings for this procedure were a series of reservoirs with a recirculation valve (CPS) and a series of cooling coils (CCS series). The Company has since developed a line of cardioplegia systems and heat exchangers designed to utilize a blood and potassium mixture and allow the surgeon to quickly change the temperature delivered to the patient.
Oxygen Saturation Monitor
In February 1992, the Company introduced a digital blood saturation monitor for open-heart surgery, the StatSat. The StatSat is an electronic device that measures the oxygen content of the patient’s blood during surgery. These readings are taken continuously and the StatSat plots the course of the blood oxygen saturation during the surgery. Although the StatSat is reusable, it uses a disposable sensor for each surgery.
Critical Care Central Venous Access Catheters and Ports
Gish’s Hemed central venous access catheter systems have applications in hyper-alimentation, chemotherapy, and long-term vascular access. The product line includes sterile single, dual and triple lumen catheters and accessories sold in kits. The triple lumen catheter that permits three substances to be administered through the same catheter was introduced during fiscal 1997. In 1993, the Company introduced an enhancement to its Hemed catheter line, the CathCap. The CathCap reduces the risk of infection at the injection site by continually bathing the injection cap in an antimicrobial solution between injections.
The Company has enhanced the Hemed line with the VasPort Implantable Ports and the VasTack Needle Support System. The VasPort consists of a silicone catheter with an implantable injection port, allowing vascular access through small needle sticks with the skin acting as a natural barrier to infection. The VasTack consists of a specially designed needle and positioning system for use with the VasPort.
The patented Orthofuser is designed for post-operative use in orthopedic surgeries, such as hip and knee replacements, and provides for the safe recovery and transfusion of the patient’s own blood. This product is well suited for orthopedic procedures, as it is portable and incorporates its own internal vacuum source. Salvaging and reusing as little as 500 ccs of blood post surgically may be enough to avoid the use of donor blood in these types of surgeries.
Designs, manufactures, and markets disposable medical devices for various surgical specialties including cardiovascular surgery, orthopedics, and oncology
ERNST & YOUNG LLP
US SIC Code
22942, Arroyo Vista
City province or state postal code
92688, RANCHO SANTA MARGARITA, CA
Phone: +1 800 938 0531
Fax: +1 949 635 6296
Country address: UNITED STATES OF AMERICA
Website url: www.gishbiomedical.com