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The InnerDyne, Inc., REVAS product is intended to provide percutaneous access to the vasculature. The REVAS product is indicated for the following use: Percutaneous vascular access.

The REVAS product consists of an expandable sleeve assembly. The tubular member of the expandable is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expandable sleeve assembly is inserted through the skin and surrounding tissue into the selected vessel over a previously placed guidewire according to the techniques of Seldinger. (An alternative placement method would have the needle placed within the lumen of the expandable sleeve, and the combined needle and sleeve inserted into the target vessel. The guidewire would be placed and the needle removed.) The dilator/sheath assembly, which consists of a tapered dilator and sheath with integral hemostasis valve, is inserted over the guidewire through the lumen of the expandable sleeve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following dilation the dilator is removed, leaving the expandable sleeve and sheath with integral hemostasis valve in place to provide a sealed port for passage of instruments. This system configuration allows the user to initially place a small diameter sheath for passage of small instruments. The sheath can then be removed from the lumion the sleeve while leaving the sleeve inserted in the vessel. A larger dirmeter dilator/sheath can then be inserted through the sleeve to create a larger port for passage of the larger instruments. The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.

The InnerDyne, Inc., RED® device is intended for use during minimally invasive surgery to provide temporary dilation access to the abdominal/peritoneal cavity and to the lumen of specified internal organs to establish a port of entry for diagnostic, therapeutic, and operative instruments. Typical procedures for product use include: - Laparoscopic access to the abdominal/peritoneal cavity; . - Percutaneous gastrostomy; . - Percutaneous enterostomy; ● - Percutaneous cystostomy; . - . Percutaneous cholescystostomy; and - . Dilation of biliary and urethral strictures.

The RED® device is an expandable dilator sheath assembly, consisting of a radially expanding sleeve, inflation syringe, cannula (with integral valve system), dilator, and insertion instrument (either an access needle or guidewire). The tubular member of the expandable sleeve is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the dilator assembly is inserted through the radially expandable sleeve, penetrating the tissue into the target cavity (e.g., abdominal/peritoneal) or hollow organ.

The InnerDyne, Inc., G-RED® device is intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures. - Percutaneous urological access, for typical procedures such as: - Percutaneous nephroscopy - Percutaneous bladder access (suprapubic) - Percutaneous laparoscopic access to primary body cavities (i.e., abdominal and thoracic), both primary and secondary punctures; and - Percutaneous access into hollow body organs.

The G-RED® device consists of an expandable dilator sheath assembly deployable via standard needle or cather/guidewire (Seldinger or similar) placement technique. The tubular member of the dilator assembly is configured so as to be axially compressed to reduce the outside than of the mandable sheath, penetrating the tissue into the target cavity (e.g., abdominal) or hollow organ. Upon use, the dilator assembly radially expands the walls of the surrounding tissue. This technique allows the user to benefit from the unique safety features and controllability of radial dilation by going from a less traumatic initial stick, followed by radial dilation to the dosire working channel. Once the working channel is established, the expandable should the working cannula in place to provide a sealed port for passage of diagnostic, therapeutic, and/or surgical instruments. This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments. The device is assembled from medical grade materials under GMP conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks. The G-RED® device is available in various lengths and working diameters to accommodate the selected size of indicated medical instruments. The subject product may be supplied in both disposable forms.

The InnerDyne, Inc., Step® device is intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures. - Laparoscopic access to the abdominal region, both primary and secondary punctures; - Thoracoscopic access to the thoracic cavity, both primary and secondary punctures; and - Percutaneous access into hollow body organs with typical use in such procedures as percutaneous gastrostomy, percutaneous enterostomy, cholecystostomy, and dilation of biliary and urethral strictures.

The Step Trocar Expandable Port Step® device consists of an expandable dilator sheath assembly with an access (Veress-type) needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal/thoracic tissue into the target cavity or hollow organ. For laparoscopic access to the abdominal/thoracic cavities, the following instructions should be utilized. After insufflation of the cavity, (if deemed necessary), the access needle is removed. The dilator cannula assembly, which consists of a blunt obturator, dilation cannula, and a pneumo valve, is inserted through the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. Following dilation the obturator is removed, leaving the expanding dilation sheath and dilator cannula in place to provide a sealed port for passage of diagnostic, therapeutic, and/or surgical instruments. For access to hollow body organs (e.g., intragastric placement viewed as typical), the following instructions should be utilized. If endoscopic technique is utilized, an endoscope is advanced into the stomach using standard techniques, followed by stomach insufflation. An abdominal incision is made and the access needle/sheath assembly is inserted directly through the abdominal and stomach walls into the stomach. The access needle is removed and the cannula/dilator is advanced through the radially expanding sleeve. If laparoscopic technique is utilized, under laparoscopic vision the abdominal cavity is entered and the stomach site is selected for insertion of the access device. The sheath/needle assembly, is advanced into the stomach. The access needle is removed, leaving the expandable sheath in place. The dilator cannula assembly is inserted through the lumen of the dilator sheath which expands radially to accommodate it. Following dilation the dilator is removed, leaving the expandable sheath and dilator cannula in place to provide a sealed port for passage of the selected instruments. Once the desired instruments are placed, the access device cannula and expanding sheath are removed, allowing the stomach and abdominal wall to contract/relax. (Access to hollow organs other than the stomach, can be achieved following general laparoscopic technique and the access methodology described above.) This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments. The device is assembled from medical grade materials under GMP conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks. The Step® radially expanding access device is available in various lengths and working diameters to accommodate the selected size of indicated medical instruments. The subject product shall be available in both disposable and reusable forms.

The InnerDyne, Inc., Radially Expanding Vascular Access System (Heparin Coated) is intended to provide percutaneous access to the vasculature. The Radially Expanding Vascular Access System (Heparin Coated) is indicated for the following usages: Percutaneous vascular access.

The Radially Expanding Vascular Access System (Heparin Coated) consists of an expandable sleeve assembly. The tubular member of the expandable is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expandable sleeve assembly is inserted through the skin and surrounding tissue into the selected ver a previously placed guidewire according to the techniques of Seldinger. (An alternative placement method would have the needle placed within the lumen of the expandable sleeve, and the combined needle and sleeve inserted into the target vessel. The guidewire would be placed and the needle removed.) The dilator/sheath assembly, which consists of a tapered dilator and sheath with integral hemostasis valve, is inserted over the guidewire through the lumen of the expandable sleeve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following dilation the dilator is removed, leaving the expandable sleeve and sheath with integral hemostasis valve in place to provide a sealed port for passage of instruments. This system configuration allows the user to initially place a small diameter sheath for passage of small instruments. The sheath can then be removed from the sleeve while leaving the sleeve inserted in the vessel. A larger diameter dilator/sheath can then be inserted through the sleeve to create a larger port for passage of the larger instruments. The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.

The InnerDyne, Inc., Radially Expanding Vascular Access System is intended to provide percutaneous access to the vasculature. The Radially Expanding Vascular Access System is indicated for the following usages: Percutaneous vascular access.

The Radially Expanding Vascular Access System consists of an expandable sleeve assembly: The tubular member of the expandable is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expandable sleeve assembly is inserted through the skin and surrounding tissue into the selected vessel over a previously placed guidewire. (An alternative placement method would have the needle placed within the lumen of the expandable sleeve, and the combined needle and sleeve inserted into the target vessel. The guidewire would be placed and the needle removed.) The dilator/sheath assembly, which consists of a tapered dilator and sheath with integral hemostasis valve, is inserted over the guidewire through the lumen of the expandable sleve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following dilator is removed, leaving the expandable sleeve and sheath with integral hemostasis valve in place to provide a sealed port for passage of instruments. This system configuration allows the user to initially place a small diameter sheath for passage of small instruments. The sheath can then be removed from the lumen of the sleeve while leaving the sleve inserted in the vessel. A larger diameter dilator/sheath can then be inserted through the sleeve to create a larger port for passage of the larger instruments. The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.

The Sherwood Medicat Company; Kangaroo®, EntriStar®; "Percutaneous Gastrostomy Kit" is a medical device for the percutaneous placement of a long-term enteral feeding tube.

The Kangaroo®, EntriStar®, "Percutaneous Gastrostomy Kit" is a sterile, single use system containing a gastrostomy tube for enteral feeding and the components required to insert the tube percutaneously, which may include endoscopic and/or laparoscopic methodology. The kit consists of a radially expanding access device, gastrostomy tube, obturator, insertion/removal device, "Y" connector, luer adapter, external retention disk, retention band, #11 scalpel, drape, gauze pads, lubricant, and Instruction for Use (IFU). The radially expanding access device is an expandable dilator sheath assembly with an access needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal tissue into the gastric cavity. If endoscopic technique is utilized, an endoscope is advanced into the stomach using standard techniques, followed by stomach insufflation. An abdominal incision is made and the access needle/sheath assembly is inserted directly through the abdominal and stomach walls into the stomach. The access needle is removed and the cannula/dilator is advanced through the radially expanding sleeve. If laparoscopic technique is utilized, under laparoscopic vision the abdominal cavity is entered and the stomach site is selected for insertion of the gastrostomy tube.

The Step®family of products are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic and operative instruments into the abdominal and thoracic cavities. The device is configured to be used as either a primary or secondary stick. The subject Open-Step® device is configured to be used with the open laparoscopic surgical approach.

The subject Open-Step® system configuration allows the user to access the desired region through open laparoscopic surgical techniques for passage of small diagnostic instruments accomplished without a radially expanding sheath. An incision is made at the target insertion site using standard technique. The surgeon places a finger into the previously created incision to ensure that a free cavity has been entered. The Open-Step®access device is inserted into the incision with the adjustable cone secured against the bottom of the cannula/dilator. The adjustable cone is slid down the cannula assembly and into the incision, helping to form an adequate seal. Position the desired cannula depth into the cavity by advancing or retracting the cannula assembly. The dilator cannula can then be removed from the lumen of the cannula while leaving the cannula inserted through the tissues creating an access/passage route for operative instruments. The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.

The Step®family of products are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic and operative instruments into the abdominal and thoracic cavities. The device is configured to be used as either a primary or secondary stick.

The Step® family of products consist of an expandable dilator sheath assembly with an access (Veress-type) needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal/thoracic tissue into the abdominal/thoracic cavity. After insufflation of the cavity, (if deemed necessary), the access needle is removed. The dilator cannula assembly, which consists of a blunt obturator, dilation cannula, and a pneumo valve, is inserted through the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. Following dilation the obturator is removed, leaving the expanding dilation sheath and dilator cannula in place to provide a sealed port for passage of diagnostic and surgical instruments. This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments.

The Step®family of products are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic and operative instruments into the abdominal and thoracic cavities. The device is configured to be used as either a primary or secondary stick.

The Step® family of products consist of an expandable dilator sheath assembly with an access (Veress-type) needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal/thoracic tissue into the abdominal/thoracic cavity. After insufflation of the cavity, (if deemed necessary), the access needle is removed. The dilator cannula assembly, which consists of a blunt obturator, dilation cannula, and a pneumo valve, is inserted through the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. Following dilation the obturator is removed, leaving the expanding dilation sheath and dilator cannula in place to provide a sealed port for passage of diagnostic and surgical instruments. This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments. The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.