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The Visicoil MR Marker and the Pre-Loaded Visicoil MR Marker are indicated for use to radiographically mark soft tissue for future therapeutic procedures.

Device Identification: the Visicoil MR is a helically wound coil of platinum wire. The product is available on a carrier for user-loaded implantation or pre-loaded in a needle. Device Characteristics: The Visicoil MR is a linear fiducial marker. It is used for marking soft tissue for future therapeutic procedures. Environment for Use: The Visicoil MR and Pre-Loaded Visicoil MR may be implanted in a healthcare facility, free standing clinic or physician's office. Description of Device: The Visicoil MR Marker and the Pre-loaded Visicoil MR Marker is a sterile device, in the form of a platinum coil. Visicoil MR comes on a delivery system, packaged in a Mylar/Tyvek pouch, sterilized by gamma sterilization. The Pre-Loaded Visicoil MR comes in a 18, 19, 20, 21, or 22g 304 stainless steel needle and stylet with a beeswax plug at the tip, packaged in a Mylar/Tyvek pouch sterilized by EO sterilization. The coils ranges in length from 0.3cm to 2cm and have an outside diameter that ranges between 0.3mm and 1.0mm. Platinum has a dense mass which allows for imaging in all x-ray based imaging devices and other electro-magnetic properties help to enhance visibility within Magnetic Resonance Imaging (MRI). The device is a passive device and is permanently implanted in the patient.

Pre-Loaded CK Visicoil Gold Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The Pre-Loaded CK Visicoil a sterile device, in the form of two gold coils and a PGLA spacer loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.2mm. The Pre-Loaded CK Visicoil is packaged sterile, for single use. Sterilization is achieved by a validated EO sterilization method. The Pre-Loaded CK Visicoil will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures. Depending on the coil size (0.35mm, 0.50mm, 0.75mm, or 1.2mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coils and spacer are supplied loaded and ready for use in the applicable needle.

The Pre-Loaded Visicoil is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The Pre-Loaded Visicoil a sterile device, in the form of a gold coil loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.2mm. The Pre-Loaded Visicoil is packaged sterile, for single use. Sterilization is achieved by a validated EO sterilization method. Depending on the coil size (0.35mm, 0.75mm, or 1.2mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coil is supplied loaded and ready for use in the applicable needle.

RadioMed™ Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The RadioMed™ Marker is a non-sterile, disposable device in the form of a rhodium coil that is 0.35mm in diameter.

GENETRA ™ with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized tumors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent turnors. GENETRA may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

GENETRA ™ utilizes Pd-103 as the radionuclide for brachytherapy. GENETRA™ exists in the form of a coiled rhodium wire. The rhodium matrix also provides the radiopacity of the device. GENETRA™ is a naturally sealed source in the form of a wire. GENETRA™ is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave. GENETRA™ will be manufactured, labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to specifications. The devices will be tested in accordance with Standard Operating Procedures. The sources are delivered using a 19 gauge needle and stylet.