Search Results

The STRATA™ Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool. The tamper resistant design helps ensure that the valve's performance level is not inadvertently changed.

The STRATA™ Valve incorporates a ball and cone pressure valve in series with a normally closed siphon control mechanism. This combination enables the valve to maintain intraventricular pressure (IVP) within a normal physiological range, regardless of a patient's CSF flow requirements or body position. Similar to the Hakim Programmable Valve and the Sophysa Pressure Adjustable Valve, the STRATA™ Valve incorporates the following features: (1) valve mechanism (spring biased ball in cone/seat), (2) 316L Stainless Steel spring coils for pressure flow regulation, (3) internal magnet, (4) valve element (ruby), (5) outer jacket (silicone elastomer). Additionally, the STRATA™ Valve incorporates a tamper-resistant internal dis-adjustment mechanism to prevent extreme changes in pressure (i.e., from the highest to the lowest settings) and a strong return spring to stabilize the rotor. The STRATA Valve is available with the BioGlide surface modification, identical to that reviewed under K951258. The product is also provided as part of a shunt configuration equivalent to that reviewed under K900676 and K951258. The shunt consists of the valve and a proximal and distal catheter, equivalent to those reviewed under K792007 and K792005.

The polyurethane-coated Delta Valves, polyurethane-coated CSF-Flow Control Valves, Contoured, and Burr Hole are components of polyurethane shunt systems designed for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity. The Polyurethane shunt and shunt components are designed to eliminate patient exposure to silicone elastomer. The polyurethane-coated Delta Valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient sits, stands, or is held erect).

A Ventricular Catheter manufactured of Polyurethane tubing. A Flow Control Valve manufactured of a Polypropylene base and a silicone elastomer housing which incorporates a Tecoflex elastomer resin, polyurethane coating. A Cardiac/Peritoneal Catheter manufactured of Polyurethane tubina.

The Introducer Sheath is a device used to make a channel through the brain into the ventricular system.

The Introducer Sheath includes two parts, a peelaway sheath and a blunt ended obturator, which fits inside the sheath. The Introducer Sheath provides an atraumatic passage into the ventricular system.

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to reduce intracranial pressure (ICP), e.g. preintra- or postoperative; monitor CSF chemistry, cytology and physiology; provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with severe head injury; subarachnoid hemormage graded III, IV or V preoperatively; Reyes syndrome or similar encephalopathies; hydrocephalus; intracranial hemorrhage or miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions.

The Medtronic PS Medical Becker EDMS is indicated for the draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space. The Becker EDMS is substantially equivalent in indications, materials of fabrication, performance characteristics and design specifications as compared with the predicate device, Codman External Drainage System II. The materials utilized in the Becker EDMS are not substantially different to those used in currently marketed products. The Becker EDMS is comprised of a nondistensible blue striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, three non-latex iniection sites, and a removable drainage bag with approximate volumetric graduations and microbial filter. A graduated 50 cc flow chamber with drip former and conical bottom and locking bracket is included on the main system section.

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to 1. Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative; 2. Monitor CSF chemistry, cytology and physiology; 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with 1. Severe head injury; 2. Subarachnoid hemorrhage graded III, IV or V preoperatively; 3. Reves syndrome or similar encephalopathies; 4. Hydrocephalus; 5. Intracranial hemorrhage 6. Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions.

The reusable portion of the system is comprised of a pressure scale, mounting clamp and optional laser level. All components of the reusable device are integrated during manufacture. The scale has a blue anodized finish with contrasting pressure scale. Down the center of the scale is a track for the disposable device to be retained. The scale is integrated into a pole clamp that has been ergonomically designed to facilitate use. An optional laser device may be attached to the pole clamp. It is used to obtain a zero pressure reference with the patients Foramen of Monro. The disposable device is comprised of three basic elements: a patient line that is attached to an externalized CSF drainage catheter, graduated drip chamber, and drainage bag. The drip chamber has an integrated mounting bracket that is inserted into the track on the reusable scale.