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The EnCor Enspire™ Breast Biopsy System is indicated to acquire breast tissue for histologic examination with partial or complete removal of the abnormality.

The EnCor Enspire™ Breast Biopsy System provides control operations for specialized biopsy instruments intended to acquire tissue samples of suspected breast abnormalities for diagnostic sampling. The EnCor Enspire™ Breast Biopsy System may be utilized with ultrasound, stereotactic, or MRI imaging guidance during the biopsy procedure. The EnCor Enspire™ Breast Biopsy System may be used with the EnCor™ Probes and EnCor™ Drivers. The EnCor Enspire™ Breast Biopsy System is reusable and provided non-sterile. The EnCor™ Probe is a handheld biopsy probe used as part of a vacuum-assisted breast biopsy system. The EnCor™ Probe is meant to be used with an EnCor Enspire™ Breast Biopsy System or an EnCor™ Breast Biopsy System. The EnCor™ Probe is provided sterile and is intended for single use. The EnCor™ Drivers are handheld units for ultrasound quided breast biopsies and for mounting on stereotactic platforms using adapters. The EnCor™ Drivers are reusable and provided nonsterile.

The EnCor™ Breast Biopsy Probe with Rinse Tube is indicated to acquire tissue for diagnostic sampling of breast abnormalities and saline rinse the tissue samples collected within the tissue chamber during a biopsy procedure. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The EnCor™ Breast Biopsy Probe with Rinse Tube is a handheld, single use, sterile (irradiation) biopsy probe used as part of a vacuum-assisted biopsy system (EnCor™ or EnCor Enspire™) and is intended to be used with ultrasound or stereotactic guidance. The probe is used for diagnostic sampling during a breast biopsy procedure. The device consists of a cutter/cannula with a sharp trocar tip, housing, sample container, vacuum and rinse tubing, and a rinse subcassette. A stainless steel cutter acquires the tissue samples, which are transported by vacuum to the probe's sample container, where they may be rinsed with saline. The EnCor™ Breast Biopsy Probe with Rinse Tube is available in 7 gauge, and 12 gauge, in both standard and vertical orientations for each qauge size.

The EnCor® Introducer is used with the EnCor® biopsy probe to penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.

The ENCOR® MRI Introducer Set consists of a Trocar, Obturator, Cannula and Needle Guide Block. The Trocar, Obturator, and ENCOR® MRI probes can be used co-axially with the Cannula. When inserted in the cannula, the tip of the Obturator approximates the center of the sample aperture of the ENCOR® MRI Probe. Markings on the Cannula indicate the distance to the center of the ENCOR® MRI probe sample aperture. The ENCOR® Probe Introducer is sterile, disposable and consists of an Introducer and Adapter. The ENCOR® Probe Introducer is used co-axially with the ENCOR® biopsy probe. The same Introducer allows for both tissue acquisition with an ENCOR® probe and subsequent marking of the biopsy site with GEL MARK ULTRACOR® Biopsy site marker.

The Breast Tissue Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

The StarchMark® Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker. The marker contains six polysaccharide (starch) pellets and one polylactic/polyglycolic acid-based copolymer (PLA/PGA) pellet which are essentially resorbed by the body after approximately 2 weeks. The polysaccharide pellets absorb body fluids to help in the control and management of bleeding. The PLA/PGA pellet contains a Stainless Steel Ribbon or "V" shaped wireform. The wireform is intended for long-term radiographic marking of the biopsy site. The StarchMark® Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure. The StarchMark UltraCor™ Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker contains four polysaccharide (starch) pellets and one polyethylene glycol (PEG) pellet which are essentially resorbed by the body after approximately 2 weeks. The polysaccharide pellets absorb body fluids to help in the control and management of bleeding. The PEG pellet contains a Stainless Steel "V" shaped wireform. The wireform is intended for longterm radiographic marking of the biopsy site. The StarchMark UltraCor™ Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.

The EnCor Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the EnCor Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The EnCor Breast Biopsy System with its 7 and 10-Gauge biopsy probes has the following similarities with the predicate devices: same intended use; same design; same patient contacting materials; same operating principle; and same technological characteristics.

The Contura Cavity Maintenance Catheter is temporarily implanted in the lumpectomy cavity as a placeholder until it is exchanged for the Contura MLB Applicator.

The Contura Cavity Maintenance Catheter consists of a dual lumen silicone catheter with an inflatable balloon at its distal end. Two proximal ports are provided with Luer-type connectors for balloon inflation/deflation and for application of intracavitary vacuum. The Contura CMC is available in a spherical, 3.5-5.0 cm diameter balloon size.

The Contura Lumen Marker is an accessory to the Contura MLB Applicator intended to be used to identify treatment lumens for radiation therapy dose planning.

Re-usable devices that aid in the identification of lumens within the Contura MLB Applicator. Each marker is 237 mm in length.

The StarchMark Biopsy Site Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

The StarchMark Biopsy Site Marker is a sterile, disposable applicator containing 4 resorbable polysaccharide (starch) pellets and a polylactic/polyglycolic acid-based co-polymer (PLA/PGA) pellet with an embedded radiopaque wireform.

The Prostate Tissue Marker is indicated for use to radiographically mark prostate tissue.

The Prostate Tissue Marker consists of a pure gold marker placed inside a 17 Ga disposable beveled needle applicator. Also contained in the needle are 2 resorbable polylactic acid/polyglycolic acid (PLA/PGA) pellets and a polyethylene glycol (PEG) plug in the needle bevel. The gold marker is intended for long-term radiographic marking of the tissue site. The pellets are visible via ultrasound for approximately 4 weeks and are essentially resorbed in approximately 12 weeks.

The Contura Multi-Lumen Balloon Source 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.

The Contura MLB Applicator consists of a multi-lumen catheter connected to an inflatable spherical balloon that can be attached to commercially available High Dose Rate remote afterloader equipment for passage of the radiation source delivery wire. Five radiation source wire lumens are provided; one central lumen located along the long axis of the applicator and four lumens symmetrically offset from the central lumen. The balloon is inflated to a 4.5 - 6 cm spherical shape by a controlled volume injection of a saline/contrast solution.