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Gelweave Vascular Prosthesis (with the exception of Valsalva variant) are indicated for the repair of damaged and diseased vessels of the thoracic and abdominal aorta in cases of aneurysm, dissection or occlusive disease. Branched configurations can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures. Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair. Gelweave Valsalva Vascular Prosthesis are indicated for the repair or replacement of damaged and diseased thoracic aorta, such as aortic root replacement in cases of aneurysm or dissection.

Gelweave™ vascular prostheses are gelatin sealed woven polyester prostheses designed for vascular repair. The Gelweave™ polyester vascular prostheses family, which is this pre-market notification, is based on woven polyester textile technology.

Gelsoft™ Plus Vascular Prostheses are indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries.

Gelsoft™ Plus vascular prostheses are gelatin sealed knitted polyester prosther repair. The Gelsoft™ Plus polyester vascular prosthesis family, which is the subject of this pre-market notification, is based on knitted polyester textile technology.

Advanta VXT and Flixene vascular grafts are indicated for use in patients with peripheral vascular disease, where peripheral arteries must be repaired or replaced and open surgery is required. Indications for use also includes patients with end stage renal disease requiring arteriovenous vascular access for dialysis.

Atrium ePTFE vascular grafts are offered in a variety of designs; (including Advanta VXT and Flixene). They are made primarily of expanded polytetrafluoroethylene (ePTFE), and are available in a wide variety of configurations: - . "Rings" (also referred to as "helix") for added radial support (made from a PTFE monofilament coil) - . The Slider Graft Deployment System consisting of a pre-attached tip(s) with a clear flexible sheath (polyethylene) - . Tapered end - . Thin or standard wall thickness The Advanta VXT graft is a 2-layer graft employing a single-layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. The rings available on some Advanta VXT grafts are bonded to the exterior surface of the graft. By following the prescribed procedure, the rings can be removed incrementally as needed. The Flixene vascular graft is a 3layer graft comprised of ePTFE. This graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary. Implantable portion of graft is comprised of polytetrafluoroethylene (PTFE) with no more than 0.1% cobalt chromite blue-green Spinel ink on surface of the graft, which is used as a reference line. Additional materials in transient contact during placement of the graft include 303 stainless steel and polyethylene, which represents the graft deployment system and transfer sleeve.

The GORE® PROPATEN® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering from occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.

GORE® PROPATEN® Vascular Graft is intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

The GORE® ACUSEAL Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access. The GORE® ACUSEAL Vascular Graft is a multi-layer vascular graft with a low bleed layer between the inner and outer layers of ePTFE (expanded polytetrafluoroethylene). The luminal surface of the inner graft component is coated with the CBAS® Heparin Surface.

The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines as patients who: • Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts). • Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography. • Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage). • Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography. • Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography. • Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis which provides arterial venous access with continuous outflow into the central venous system. The HeRO Graft is composed of the following components: (1) Venous Outflow Component (VOC) with delivery stylet, (2) Arterial Graft Component (AGC) or HeRO Adapter with Support Seal (used in conjunction with commercial vascular grafts), and (3) Accessory Component Kit (ACK). The VOC consists of a radiopaque silicone base tube, a nitinol braid (imparts kink and crush resistance), a distal radiopaque marker band, and an outer silicone elastomer encapsulation layer. During surgery, the VOC is cut to length for the patient anatomy and then advanced over the barbs of the AGC Connector or HeRO Adapter. The AGC is a conventional ePTFE vascular graft with a guideline and beading near the custom titanium alloy connector to provide kink resistance. As an alternative to the AGC, the titanium alloy HeRO Adapter with Support Seal allow the clinician to choose one of the commercially available 6mm ID vascular grafts qualified for use with the HeRO Graft. The HeRO Graft Accessory Component Kit is intended to aid in the implantation of the HeRO Graft and contains instruments including, introducers, dilators, hemostasis valve with stopcock, disposable clamp, and hemostasis plug. The HeRO Graft is a fully subcutaneous surgical implant single-use device provided sterile via ethylene oxide for long-term (>30 day) use.

The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.