Search Results

The Catalyst II " System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Catalyst II System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using SF, 6F or 7F introducer sheaths. The Catalyst™ III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Catalyst™ III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

The Cardiva Catalyst systems are intended to promote hemostasis at arteriotomy sites as adjuncts to manual compression and retain the same indication for use as the Boomerang Catalyst System family of devices. The Cardiva Catalyst systems consist of a sterile disposable Cardiva Catalyst wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III System is specifically designed for use with heparinized patients. In conjunction with manual compression, the Cardiva Catalyst systems provide temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Cardiva Catalyst wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Cardiva Catalyst wire is deployed, which opens a flat, low-profile Catalyst Disc within the lumen of the femoral artery. During dwell, natural recoil of the smooth muscle of the vessel wall occurs at the arteriotomy site. A biocompatible coating on the Cardiva Catalyst III Wire aides the body's natural hemostatic process and promotes ease of removal. Specifically, the Cardiva Catalyst III System's biocompatible coating includes a minimal amount of Protamine Sulfate to further aid the body's natural hemostatic process in heparinized patients. Following the procedure, the Catalyst Disc is collapsed and the Cardiva Catalyst III wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Cardiva Catalyst III System.

The Cardiva Catalyst™ III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst™ III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

The Cardiva Catalyst™ III System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst III system includes a design modification which involves the addition of Protamine Sulfate to the existing Boomerang Catalyst II System coating to further minimize ocze from the tissue tract and promote the hemostasis process in heparinized patients. The Cardiva Catalyst III System maintains the same indication for use as the Boomerang Catalyst System family of devices. The Cardiva Catalyst III System consists of a sterile disposable Cardiva Catalyst III wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III System is specifically designed for use with heparinized patients. In conjunction with manual compression, the Cardiva Catalyst III System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Cardiva Catalyst III wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Cardiva Catalyst III wire is deployed, which opens the flat, low-profile Catalyst Disc within the lumen of the femoral artery. During dwell, natural recoil of the smooth muscle of the vessel wall occurs at the arteriotomy site. A biocompatible coating on the Cardiva Catalyst III Wire aides the body's natural hemostatic process and promotes ease of removal. Specifically, the Cardiva Catalyst III System's biocompatible coating includes a minimal amount of Protamine Sulfate to further aid the body's natural hemostatic process in heparinized patients. Following the procedure, the Catalyst Disc is collapsed and the Cardiva Catalyst III wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Cardiva Catalyst III System.

The Boomerang™ Catalyst/Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Catalyst/Catalyst II System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

The Boomerang™ Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang Catalyst II System includes design modifications to minimize ooze from the tissue tract and promote the hemostasis process. The Boomerang Catalyst II System maintains the same indication for use as the Boomerang Catalyst System family of devices, formerly referred to as the Boomerang PlusWire System. The Boomerang Catalyst II System consists of a sterile disposable Boomerang Catalyst II wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang Catalyst II System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Catalyst II wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Catalyst II wire is deployed, which opens the flat, lowprofile Boomerang Disc within the lumen of the femoral artery. The introducer sheath is then removed from the vessel over the Boomerang Catalyst II wire and the low-profile Boomerang Disc conforms to the contours of the vessel and secures it against the intima, sealing the arteriotomy. As gentle tension is applied to the Boomerang Catalyst II wire, the sleeve covering the tensioning coil is gently retracted until the distal tip appears at the skin surface to expose the coated tensioning coil to the tissue tract. The applied tension is maintained by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Catalyst II wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Boomerang Catalyst II System.

The Boomerang™ Wire/PlusWire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire/PlusWire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

The Boomerang™ Plus Wire System is an extension of the Boomerang Wire System family of devices. The Boomerang Plus Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Plus Wire System includes design modifications to enhance ease of device removal and to minimize ooze from the tissue tract. The Boomerang Plus Wire System maintains the same indication for use as the Boomerang Wire System family of devices. The Boomerang Plus Wire System consists of a sterile disposable Boomerang Plus Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang PlusWire System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Plus Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Plus Wire is deployed, which opens the flat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Plus Wire and the low-profile Boomerang Disc conforms to the contours of the vessel and secures it against the intima, sealing the arteriotomy. As gentle tension is applied to the Boomerang Plus Wire, the sleeve covering the tensioning coil is gently retracted until the distal tip appears at the skin surface to expose the coated tensioning coil to the tissue tract. The applied tension is maintained by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Plus Wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Boomerang Plus Wire System.

The Cardiva Medical Boomerang™ Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5, 6 or 7 Fr introducer sheaths.

The Boomerang™ Wire System consists of a sterile disposable Boomerang Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang Wire System provides hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Wire is deployed, which open the flat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Wire and the low-profile Boomerang Disc is positioned against the inside of the arteriotomy. Gentle upward tension is applied to the Boomerang Wire, which conforms the Boomerang Disc to the contours of the vessel and secures it against the intima, sealing the arteriotomy. The tension is then held in place by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Wire is completely removed for the artery. No part of the device is left behind nor is there any material introduced to alter the body's own natural clotting process. Final closure of the vessel occurs with manual compression to close the remaining needle puncture site left by removing the Boomerang Wire.

The Cardiva Medical Boomerang™ Wire is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.

The Boomerang™ Wire consists of a sterile disposable Boomerang Wire and a sterile disposable Boomerang Clip (refer to the detailed Figures 1,2,3 in Section VIII). In conjunction with manual compression, the Boomerang Wire provides hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Wire is deployed, which opens the ffat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Wire and the low-profile Boomerang Disc is positioned against the inside of the arteriotomy. Gentle upward tension is applied to the Boomerang Wire, which conforms the Boomerang Disc to the contours of the vessel and secures it against the intima, sealing the arteriotomy. The tension is then held in place by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Wire is completely removed from the artery. No part of the device is left behind nor is there any material introduced to alter the body's own natural clotting process. Final closure of the vessel occurs with manual compression to close the remaining needle puncture site left by removing the Boomerang Wire.

The Cardiva Medical VasoStasis™ Vascular Closure System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The VasoStasis Vascular Closure System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.

The VasoStasis Vascular Closure System consists of the following components: (1) a sterile. disposable catheter (VasoStasis™ VCS Catheter), and (2) a sterile, disposable tensioning device (VasoStasis™ VCS Tensioner). The VasoStasis Vascular Closure System, in conjunction with manual compression, provides hemostasis at femoral access sites after femoral arterial catheterization while allowing continued perfusion of the lower extremities. The VasoStasis VCS Catheter is a single lumen, low profile catheter with an elastomeric membrane at the distal tip. The membrane is covered by a tip guide, which protects the membrane as the cledeployed catheter is inserted into the artery through a previously placed introducer sheath. A small loon handle is at the proximal end of the device and moves axially to deploy or de-deploy a Nitinol coil within the membrane. Once the catheter is introduced into the vessel, the membrane is positioned distal to the introducer sheath and deployed by pushing the loop handle forward. In its fully deployed state, the membrane nominally achieves 13 F in diameter. The Cardiva VasoStasis VCS Tensioner clips on the VasoStasis VCS Catheter shaft on the surface of the skin at the entrance to the arteriotomy and holds the catheter secure while the membrane is deployed in the vessel.