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Best® Intraluminal Balloon Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intraluminal radiation to an existing body lumen such as the esophagus or bronchus. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician.

The Best® device is a single catheter brachytherapy device consisting of an inflatable distal spherical balloon for anchoring and/or stabilizing and a series of inflatable balloons for centering the treatment catheter within the lumen. The catheter can be attachment to a commercially available High Dose Rate remote afterloader for passage of the source wire and radiation source into the catheter lumen. A removable flexible guide cable is positioned in the central treatment catheter for initial placement in the existing body lumen. Proximal ports are also provided with Luer-lock type connectors for inflation of the distal anchoring/stabilizing balloon inflation/deflation and for inflation of the series of centering balloons, either simultaneously or individually.

"Best® Multi-Lumen Balloon Applicator for Brachytherapy" is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician.

The Best® device is a multi-catheter brachytherapy device consisting of an inflatable outer spherical balloon and an inner inflatable balloon for treatment catheter positioning. Each catheter can be attachment to a commercially available High Dose Rate remote afterloader for passage of the source wire and radiation source into each of the catheter lumens. Five treatment lumens are provided, one central lumen located along the long axis of the applicator and four moveable lumens, which are symmetrically offset from the central lumen by inflation of an inner balloon, which positions the treatment lumens at a location greater than or equal to 50% of the outer balloon diameter. A removable stiffening stylet is positioned in the central treatment lumen for initial placement into the resection cavity, as well for repositioning of the device as needed. Three proximal ports are also provided with Luer-locktype connectors for inner and outer balloon inflation/deflation and for application of intracavitary vacuum for removal of air and/or fluid.

The Best Medical International, Inc Best Strand component device is indicated for use as an accessory in brachytherapy procedures. It is supplied sterile, as a single-use device. The Best Strand is indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures. The Best Medical International, Inc., "Best Spacer" device is intended to be used to maintain a predetermined space between radionuclide seeds during the introduction of the seeds into the body during Brachytherapy procedures. Absorbable spacers are indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.

The Best Medical International, Inc, Best Strand consists of synthetic absorbable polymer or copolymer matcrial, braided and non-braided, which is used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures.

The Best Radiopaque Strand (Marker Strand) is made of radiopaque xxx markers (i.e, seeds) and absorbable spacers, inside an absorbable strand, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures. The Best Radiopaque Marker (Marker) is made of a radiopaque xxx solid seed, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures.

The Best Radiopaque Strand (marker strand) is composed of two radiopaque markers, separated by absorbable spacers, and enclosed in an absorbable strand. It is supplied sterile. The Best Radiopaque Marker (marker) is composed of a radiopaque nonradioactive seed (gold, platinum, stainless steel, titanium, or tungsten) which is supplied non-sterile. The placement of the markers and marker strand in soft tissue, prior to therapeutic procedures, allows better dosimety coverage of the targeted site due to clearer identification of the anatomic regions.

The BEST Model No. 81-01 Series Sources are intended for the delivery of therapeutic doses of gamma radiation for the purpose of brachytherapy treatments (e.g., interstitial, intracavitary, intralumen, or topical radiation therapy).

BEST Model Nos. 81-01-11, 81-01-14, and 81-01-14 sources. These sources are pure Ir-192 sources.