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The Altis® Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Coloplast Altis Single Incision Sling (SIS) System includes an implantable, non-absorbable, single incision mid-urethral sling and disposable introducer needles for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Altis sling is knitted to 1.1 cm width using a 0.08mm (nominal) diameter polypropylene filament and is 7.75 cm long. The Altis sling and Altis introducers are provided sterile (ethylene oxide sterilization) and are for single-use only.

The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.

The Saffron Fixation System consists of a single-use disposable Saffron Fixation Tool (delivery tool) and implantable tissue fixation Saffron Anchors (packaged and sold separately) made of polysulfone that are intended to be compatible with commercially available sutures up to size 0 (not provided as a part of the system). The delivery tool facilitates anchor placement with or without direct visualization and may be used to implant multiple anchors in a single patient as needed by the surgeon. The fixation anchors are multi-barbed hooks that provide permanent fixation points for suture attachment to the sacrospinous ligament.

Biatain® Silicone Ag is intended to provide a moist wound environment and exudate management of acute and chronic wounds. Biatain® Silicone Ag is indicated for the management of exuding leg and foot ulcers, diabetic foot ulcers, superficial and partial thickness burns, donor sites, and, traumatic and post-operative wounds.

The device is available as sterile, single use only. The device is intended to provide a moist environment and exudate management of acute and chronic wounds. The device maintains a moist wound providing the optimal environment for wound healing. The device consists of: - Polyurethane (PU) top film - a 25 um semi-permeable barrier, printed with grey dots. - . Absorbing pad - composed of a 3.0 mm PU foam containing an anti-bacterial silver complex (silver sodium hydrogen zirconium phosphate). - Silicone adhesive bi-layer composed of a middle PU film . with a silicone adhesive gel. The PU top film and the middle PU film are laminated together at the border. - . Protective film - composed of three or five parts; the center part and the remaining side parts. The device: - . contains a silver compound (silver sodium hydrogen zirconium phosphate). In vitro testing demonstrated that Biatain® Silicone Ag has an antimicrobial effect in the dressing against the following strains of 3 gram positive bacteria, 3 gram negative bacteria, 1 yeast, and 1 mold: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis, Klebsiella pneumoniae, Escherichia coli, Aspergillus brasiliensis and Meyerozyma guilliermondii. The dressing sustains antimicrobial activity for up to 7 days. The device may be used in hospitals, healthcare facilities, and home care. Sterilized using ethylene oxide (EO). Prescription Use Only.

The ReTrace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

The ReTrace Ureteral Access Sheath is comprised of the following components: Reinforced tube/sheath, Introducer/dilator, Connector, Clip. The reinforced polymeric introducer sheath includes a hydrophilic coating on the exterior and a lubricious inner surface. The sheath is reinforced to provide kink resistance. The distal tip of the sheath is fitted with a radiopaque ring. A white connector and orange clip is fitted on the proximal end of the sheath. The introducer is fitted with a Luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and exit holes for fluid delivery are located at the distal end of the introducer. This submission expands the product line to include 28 cm long and 55 cm long sheaths with inner diameters of 10 and 12 Fr.

The Digitex Delivery Device is a single-use device intended for use as an aid in suturing transvaginal pelvic organ prolapse procedures with surgical mesh.

The Digitex® Suture Delivery System is composed of a delivery device and suture cartridge and is designed for use by the physician to facilitate the consistent placement of suture when direct visualization is not possible and/or the anatomical location is difficult to reach. The shaft of the device has been designed to allow for adjusting the angle of the needle housing to further facilitate suture placement in the desired location.

The Peristeen™ Anal Irrigation System is intended to instill water into the colon through a rectal catheter - which incorporates an inflatable balloon - inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen Anal Irrigation System is indicated for use by children (2 years -< 12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

The Peristeen™ Anal Irrigation (PAI) System is a Class II device intended for intermittent use that facilitates emptying of the colon/bowel in patients with neurogenic bowel dysfunction. The PAI system consists of a single-use irrigation catheter that incorporates an inflatable balloon to keep the catheter in place during the procedure and retain the water that flows into the colon. The rectal catheter is non-sterile, intended for single-use, and packaged and labeled accordingly. The other components may be used multiple times; usage guidelines are detailed in the labeling. All System components are also provided separately in various accessory packages.

SpeediCath Compact Eve is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The catheter is for female patients only.

The SpeediCath Compact Eve is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the handle is turned to break the packaging, connect a urine bag to the end of the handle, if required, and the catheter is pulled out of the packaging. The catheter is then ready to use allowing easy handling and urine to flow through the catheter and handle.

The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.

The Orchestra® Hydrophilic Guidewire is a guidewire consisting of a metallic core wire with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. The guidewire is supplied sterile and non-pyrogenic.

SpeediCath Compact Male is indicated for use by patients with urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The catheter is for male patients.

The SpeediCath Compact Male is a sterile, single use, disposable polyurethane catheter for males. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. To prepare the catheter for use, the cover is removed and the catheter is pulled out of the packaging thereby extending and locking it to its full length. The catheter is then ready to use allowing easy drainage.

The Re-Trace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

The Re-Trace Ureteral Access Sheath is comprised of the following components: Reinforced tube/sheath, Introducer/dilator, Connector, Clip. The reinforced introducer sheath is composed of a polyether block amide (PEBA) outer surface with a hydrophilic coating. The inner surface of the sheath is polytetralluoroethylene (PTFF). The sheath is reinforced with a stainless steel coil between the PEBA and PTFE materials. The distal tip of the sheath is fitted with a radiopaque ring. A white connector and orange clip is fitted on the proximal end of the sheath. The introducer/dilator is a radiopaque polyvinyl chloride (PVC). The introducer is fitted with a luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and three exit holes for fluid delivery are located at the distal end of the introducer. A 4cm length Nitinol tube is inserted in the injection channel of the introducer to stiffen the guide wire exit eye section of this introducer.