| MAKO Surgical Corp. (MAKO)
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MAKO Surgical Corp. (MAKO),incorporated on November 12, 2004, is a medical device company, which markets its advanced robotic arm solution, joint specific applications for the knee and hip and orthopedic implants for orthopedic procedures.
The Company offers MAKOplasty, a restorative surgical solution that enables orthopedic surgeons to treat patient specific, osteoarthritic disease. MAKOplasty is performed using the Company's RIO Robotic Arm Interactive Orthopedic system (RIO). The RIO is a technology platform that utilizes tactile guided robotic arm technology and patient specific planning and visualization to offer reproducible precision to surgeons. The RIO is used to treat early to mid-stage osteoarthritic knee disease and osteoarthritic hip disease. In October 2013, MAKO Surgical Corp. completed the acquisition of Pipeline Biomedical Holdings, Inc.'s business, which is engaged in the design, development, manufacture and commercialization of orthopedic devices and related instruments for use with both robotic devices and manual medical procedures.
The Company offers MAKOplasty Partial Knee Arthroplasty, or MAKOplasty PKA, and MAKOplasty Total Hip Arthroplasty, or MAKOplasty THA. The Company also offers MAKOplasty THA, a surgical solution that enables orthopedic surgeons to perform total hip arthroplasty with the same potential for consistently reproducible precision, accuracy, and dexterity as MAKOplasty PKA.
The MAKO RIO Robotic Arm Interactive Orthopedic System
The centerpiece of MAKOplasty is the RIO system, the Company's robotic arm, interactive, orthopedic system, that provides both pre-operative and intra-operative guidance to the orthopedic surgeon, enabling tissue sparing bone removal and accurate implant insertion and alignment. The RIO system consists of two elements: a tactile robotic arm utilizing an integrated bone cutting instrument and a patient specific visualization component. The tactile robotic arm is designed to respond fluidly to movements initiated by the surgeon operating the bone cutting instrument. The controller is the electronic hardware and firmware component of the Company's computing system which interfaces with its surgical planning and execution software to allow the surgeon to safely guide the tactile robotic arm. The controller governs the basic, low-level functions of the tactile robotic arm, such as the tactile constraints and the safety circuit.
During a MAKOplasty procedure, the location of the tactile safety zone is updated continuously based on bone tracking data supplied to the computer system by an infrared stereo tracking system, which consists of a special camera that is directed toward a series of tracking arrays attached to the patient's anatomy by bone pins. The tracking system assists the robotic arm system in locating and physically tracking the patient's anatomy and coordinating its real time position with the cutting instrument of the robotic arm. It has a sufficient refresh rate to provide the robotic arm system with an adequate flow of information regarding movements of both the patient and the robotic arm to ensure optimal cutting and placement. The end effector is the mechanical component by which the bone cutting instrument is attached to the tactile robotic arm. It is designed to ensure secure placement of the bone cutting instrument, while providing the necessary for the surgeon to manipulate the instrument.
The bone cutting instrument is integrated into the tactile robotic arm at the end effector. For MAKOplasty PKA procedures, this instrument is composed of a high speed motor and a component that houses a variety of single use bone cutting tips. The design of the bone cutting instrument allows the surgeon to grip it in a manner similar to holding a pen-like cutting tool, making it easy to manipulate the instrument in the patient's anatomy. The cutting tip is the disposable end tip of the bone cutting instrument that makes contact with the joint and actually removes the bone for placement of the knee implant in accordance with the pre-operative surgical plan. In combination with the Company's tactile robotic arm, the knee bone cutting instrument enables the smooth precision and accuracy necessary for MAKOplasty PKA procedures. For MAKOplasty THA procedures, the bone cutting instrument is a reamer (similar to a drill) to which hemispherical cutting baskets are attached.
The base component of the Company's tactile robotic arm is a mobile unit that enables the portability of the tactile robotic arm from one operating room to another. The base console houses the controller and various electrical and mechanical components that help power the tactile robotic arm. Its design enables the console to be situated next to the patient during surgery and the tactile robotic arm to be conveniently positioned over the patient's anatomy.
The robotic arm enforces a tactile safety zone by providing tactile resistance when the boundaries of the tactile safety zone are reached, while the Company's patient specific visualization system provides a visual representation of the tactile safety zone and provides additional visual and auditory cues when the boundaries of such tactile safety zone are reached. The instrument locator provides visual guidance on the position of the bone cutting instrument and other surgical instruments in relation to the patient's anatomy. Prior to surgery, patients undergo a conventional CT scan that captures an image of the diseased joint. This CT image is uploaded to the patient specific visualization system for display as a 3-D volume in space. The surgeon can then virtually place the implants on the 3-D models of the patient's bones. This patient specific visualization of the Company's implant overlaid onto an image of the patient's actual joint helps the surgeon to plan the procedure pre-operatively, by providing information that enables the surgeon to determine the optimal placement, alignment and sizing of the implant. The final planned placement of the implant establishes the boundaries of the tactile safety zone for surgery. During surgery, each monitor projects an active three dimensional (3-D) computer graphics visualization of the patient's joint, showing the areas of the bone that are actually removed as the procedure progresses.
The base component of the Company's patient specific visualization system is a mobile unit that enables the portability of the patient specific visualization system from one operating room to another. It houses the Company's computer hardware and its surgical planning and execution software and various electrical and mechanical components that help power the visualization system.
MAKOplasty PKA Products
The Company's MAKOplasty PKA application enables surgeons to isolate and resurface just one or two specific diseased compartments of the joint through a minimally invasive incision, preserving significantly more soft tissue and healthy bone of the knee. The precision provided by the Company's RIO system robotic arm and MAKOplasty PKA application makes such minimally invasive targeted treatment possible by eliminating the complex scaffold of cutting blocks and jigs that would otherwise be required to execute the blunt, planar bone cuts and insert the implants involved in conventional total knee replacement surgery or a manually executed resurfacing procedure. The MAKOplasty knee resurfacing procedure is performed by the surgeon using the surgical planning and execution joint specific application software integrated into the Company's patient specific visualization system. The figure below illustrates an actual MAKOplasty knee resurfacing procedure and the corresponding virtual representation of the MAKOplasty PKA application on the patient specific visualization system.
MAKOplasty PKA employs a knee implant system that is designed for insertion and cementation in a minimally invasive manner. The RESTORIS family of knee implant systems allows an orthopedic surgeon to treat early through mid-stage degenerative osteoarthritis of the knee with a modular implant system. The RESTORIS MCK unicompartmental and bicompartmental knee implant system offers an implant geometry to support the tissue and bone sparing goals of MAKOplasty PKA. The RESTORIS MCK system, depicted in the figures below, enables surgeons to treat patients suffering from osteoarthritis in any single compartment of the knee joint: the medial (inner), lateral (outer), or patellofemoral (sub-kneecap). The RESTORIS MCK system also enables bicompartmental treatment of the patellofemoral compartment in combination with the medial compartment.
MAKOplasty THA Products
The Company's MAKOplasty THA application utilizes the RIO system's tactile, visual and auditory feedback to assist the surgeon in preparing the acetabulum (hip socket) for optimal placement of the acetabular cup implant and femoral stem. The hip implant market, unlike the partial knee implant market, is based on multiple, differing implant philosophies, which results in orthopedic companies offering a variety of hip implants options in order to satisfy the requirements of a majority of surgeons.
The RIO system utilizes disposable products. It is associated with the Company’s patient specific visualization system and cutting instruments and other items that require disposal after each use.
The Company competes with Biomet, Inc., DePuy Orthopedics, Inc., a Johnson & Johnson company, Smith & Nephew, Inc., Stryker Corporation, Zimmer Holdings, Inc. and CUREXO Technology Corporation.
More Information for MAKO Surgical Corp. (MAKO):
Company Website - http://www.makosurgical.com
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