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Integra Radionics Inc. Acquires Neurosurgical Products From Tyco Healthcare Group LP

Integra will acquire Tyco Healthcare Group LP’s neurosurgical and radiation device products for $80 million, significantly expanding our capabilities in neurosurgery market.

Neurosurgeons rely on our intracranial monitors to continuously measure and track brain parameters such as blood flow, pressure, temperature and dissolved oxygen content in brain tissue.

Stereotactic Radiosurgery

Stereotactic Radiosurgery (SRS) is a non-invasive procedure that utilizes precisely targeted beams of radiation (gamma rays, X-rays or protons) to treat brain tumors, vascular lesions and other small diseases. SRS may be combined with other treatment modalities such as embolization therapy for maximum effectiveness.

Moffitt Cancer Center employs a team of radiosurgery experts who will evaluate a patient’s individual diagnosis to determine if SRS is the appropriate treatment option. This group includes radiation oncologists, neurosurgeons and medical physicists as part of its collaborative team. Image-guided radiation therapy may be used prior to and during SRS procedures as an aid in pinpointing tumor location; furthermore computerized treatment planning systems allow them to focus radiation beams directly onto target while taking into account depth doses, off-axis ratio and collimator output factor when planning procedures are carried out.

At SRS treatments, patients will wear an external mask tailored specifically for them and molded around the shape of their head and face in order to limit movement during radiation beam delivery. Treatment rooms feature linear accelerators which dispense radiation beams directly onto targeted areas. Sometimes multiple SRS treatments will need to be administered over time depending on tumor size and location.

Once an SRS treatment has concluded, the therapist will remove the mask and monitor the patient for several hours post-procedure. If any adverse side effects arise during this period of observation, such as generalized reaction to radiation exposure or symptoms associated with specific parts of their bodies that were treated, contact their physician or nurse immediately. Possible adverse reactions of radiation exposure could include general reaction as well as symptoms specific to any body part treated during SRS treatment.

Integra’s noninvasive SRS system XKnife is widely utilized to treat brain and spine tumors as well as lung tumors, among other locations. Integra acquired Tyco Healthcare to expand their global reach while selling the XKnife through their network of independent distributors and Tyco affiliates worldwide.

Ultrasonic Surgical Aspiration

An innovative new surgical device has been created for fragmenting and aspirating tissue particles and fluid at the operation site. The device uses ultrasonic dissection, emulsification, and aspiration within one hand-held instrument: Cavitron Ultrasonic Surgical Aspirator (CUSA). CUSA can be used in minimally invasive surgery procedures to safely debulk soft tissue tumors like neurofibromas as well as lymph nodes without damaging surrounding blood vessels or nerve fibers – it was successfully used during clinical trials to safely debulk two orbito-temporal neurofibromas as well as one cutaneous neurofibroma from three patients!

The device works by producing ultrasonic vibrations through an elongate handpiece with a longitudinally vibrating titanium tip, equipped with an irrigation passage to supply isotonic solutions and aspiration ports to apply suction at its tip. Vibrations created by its tip create shear stresses which facilitate tissue breakage, emulsification and aspiration of any remaining tissue fragments as they come loose from breaking apart the tissue matrix.

The exact nature of the interactions between hepatocytes and titanium surface tip of an oscillating tip are still poorly understood. Although cavitation is thought to play a part, other mechanisms, including direct jackhammer effect, shock-induced stress, acoustic microstreaming and shear stress could also play a part in shattering hepatocytes; blood and bile do not seem affected however.

The CUSA Excel+ incorporates a closed recirculating water cooling system to mitigate heat generated from high-frequency oscillations of its tip, while an internal sensor continuously monitors transducer frequency to maintain optimal tip vibration levels. The CUSA Excel+ is an exceptional device, capable of simultaneous fragmentation, irrigation and aspiration – making it a versatile surgical tool. Furthermore, its pulsed irrigant pump enables controlled irrigation at treatment areas. Currently available in Europe, Japan and Australia; Integra plans to offer CUSA radionics products through independent distributors throughout the US as well as Tyco Healthcare affiliates overseas.

Image-Guided Surgical Systems

Image-guided surgical systems can be used to localize surgical instruments and enable minimally invasive operations. They utilize computerized tomography (CT), magnetic resonance imaging (MRI), computed tomography angiography (CTA), X-ray, and other information as guides for surgeons during surgical procedures.

Technology has also revolutionized robotic surgery, enabling complex surgical procedures to be done less invasively and with greater precision. One such example is Intuitive Surgical’s Da Vinci system: this approach uses an internal camera to guide a robot, which in turn controls an invisible needle-like device for precise surgical maneuvers.

Neurosurgeons have access to various image-guided surgical navigation systems for precise surgical navigation. Many utilize electromagnetic localization techniques that create a magnetic field within a patient, then position and orientation sensors are located using tracking systems with high accuracy for measuring surgical instruments or probes within it.

Surgical navigation systems allow neurosurgeons to quickly match instruments’ positions in physical space with preoperative diagnostic images from CT, MRI or PET scanners. Neurosurgeons rely heavily on this data as they perform many complex and minimally invasive operations on either skull or brain structures.

Ultra-wideband (UWB) wireless technology enables video transmission at very high rates between 3.1-10.6 GHz. This opens up the potential for image-guided surgical navigation systems without cables that transmit composite images directly to surgeons’ screens near surgery locations – especially useful in retinal procedures or microscopic surgeries.

Integra LifeSciences Holdings Company of Plainsboro, New Jersey and TomoTherapy Inc. of Madison, Wisconsin have joined forces to offer the InterFix radiosurgery kit, consisting of stereotactic neurosurgical tools designed to provide precision cranial immobilization for use with Hi-Art radiation treatment system as well as provide a platform for future stereotactic and radiosurgery development applications. Shipping should start later this year with expected revenue projections reaching $60 Million within one year.

Radiation Oncology

Recent technological innovations in radiation therapy have combined high-precision dose delivery and tumor localization into one system, which may use rigid frames, special applicators such as cones or multileaf collimators (MLC) for frameless stereotactic radiosurgery (SRS). Novalis platform (Brainlab, Feldkirchen, Germany), an image-guided radiotherapy (IGRT) system recently developed, allows patients to lie prone in fixed position while two flat panel detectors mounted to the ceiling of their linear accelerator are continuously scanning them for cancer cells. As this system compares internal structures or implanted markers with digitally reconstructed radiographs from CT scans used for planning, it is capable of providing conformal doses that target irregularly shaped tumors while sparing normal tissue.

The X-Knife system comprises three-dimensional treatment planning software, stereotactic localizers and immobilizers, a miniature multileaf collimator, quality assurance instrumentation and quality management tools. When in session, a surgeon guides the robot using computer-generated images of the head and neck; additionally a Gill-Thomas-Cosman relocatable headframe may be placed by neurosurgeon under local anesthesia to immobilize skull base immobilization prior to implanting of MRI data in order to plan treatment using RT 4.0 threedimensional treatment planning software.

Surgical aspiration and radiation therapy can be effective combinations in treating brain tumors. By combining them, less treatments may be required for positive clinical results and more patients can gain from this minimally invasive therapy option.

Integra LifeSciences Holdings announced today it has acquired Tyco Healthcare Group’s Radionics division for an estimated cash payment of $80 million, further expanding Integra’s neurosurgical and radiation device portfolio, such as its CRW stereotactic brain surgery system and the X-Knife radiosurgery device.

Integra plans to integrate Radionics in Burlington, Massachusetts into its current medical device operations, with employment at their Burlington facility remaining intact and transitional supply and distribution agreements being established with Tyco Healthcare Group for products currently manufactured at facilities not included in this transaction.

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