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The Duet EDMS is indicated for draining of CSF flow from the lateral ventricles or lumbar subarachnoid space in selected patients to: - · Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative. - · Monitor CSF chemistry, cytology, and physiology. - · Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. Monitoring of intracranial pressure (ICP) is indicated in selected patients with: - · Severe head injury - · Subarachnoid hemorrhage graded III, IV, or V preoperatively - · Reyes syndrome or similar encephalopathies - · Hydrocephalus - · Intracranial hemorrhage - · 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 Duet™ External Drainage and Monitoring System (Duet™ EDMS) is a complete draining and monitoring cerebrospinal system for externally fluid (CSF) and monitoring intracranial pressure (ICP). It can be used for both external ventricular and lumbar drainage. The Duet™ EDMS is an external drainage and monitoring system that uses gravity to drain cerebrospinal fluid (CSF) from the patient's ventricles or lumbar space to an external drainage receptacle. The drainage flow of CSF into the Duet™ EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. The Duet's catheter is surgically attached to the patient before it is attached to the drainage system. An opening is made in the patient's skull lumbar region and a catheter is inserted into patient's ventricle or the lumbar or subarachnoid space. The catheter is then attached to the drainage system. The CSF or blood is drained and monitored until the patient is stabilized, the infection successfully treated, or a long-term drainage method is implemented.

The DUET EDMS is indicated for temporary draining and monitoring of cerebrospinal fluid (CSF) flow from the lumbar subarachnoid space in: 1. Patients undergoing open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA) repair surgery. 2. Patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia.

The Medtronic Duet External Drainage and Monitoring System (Duet EDMS) is a complete system for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring intracranial pressure (ICP). It can be used for both external ventricular and lumbar drainage. The Duet™ EDMS is an external drainage and monitoring system that uses gravity to drain cerebrospinal fluid (CSF) from the patient's ventricles or lumbar space to an external drainage receptacle. The drainage flow of CSF into the Duet EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. The Duet's catheter is surgically attached to the patient before it is attached to the drainage system. An opening is made in the patient's skull or lumbar region and a catheter is inserted into patient's ventricle or the lumbar subarachnoid space. The catheter is then attached to the drainage system. The CSF or blood is drained and monitored until the patient is stabilized, the infection successfully treated, or a long-term drainage method is implemented.

The StrataMR II Valves and shunts are designed to provide continuous Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasively adjust valve pressure/performance level pre-and post-implantation by using magnetic adjustment tools without the need of radiographic confirmation.

The StrataMR™ II adjustable valves are single-use implantable devices which provide a noninvasive method to address changing patient needs in the management of hydrocephalus. The valves and their associated catheters drain cerebrospinal fluid (CSF) from ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. StrataMR™ II valve incorporates a ball and cone pressure valve in series with a normally closed siphon control mechanism. Flow control is achieved, and retrograde flow is prevented by combined resistance of the ball and cone and siphon control diaphragm. Pre- and postimplantation, the performance level of the valve can be modified by StrataMR™ Adjustment Tools: Locator tool, guider tool, indicator tool and adjustment tool cleared under K181622.

Medtronic StrataMR™ Valves and Shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to noninvasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

The Medtronic StrataMR™ valves are implantable adjustable valves for the management of hydrocephalus. The valves and their associated catheters drain Cerebrospinal Fluid (CSF) from the ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. Before and after implantation, the pressure/flow characteristics of the Medtronic StrataMRTM valve can by modified by the StrataMR adjustment tool. The original StrataMR adjustment tools, including handheld locator, and adjustment tool, are designed to allow the user to determine the pressure/performance level setting of StrataMR valves and adjust the setting when needed. In this 510(k) submission, Medtronic is proposing to add an additional component, guider tool, to the StrataMR adjustment tools, to improve the method to reliably adjust the StrataMR valve, cleared in K152700.

Durepair is indicated as a dura substitute for the repair of the dura mater.

Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair is supplied sterile, in a double-peel package, and is intended for single (one-time) use-only. Durepair is available in a variety of sizes intended to be cut by the surgeon to the desired shape.

The Medtronic StrataMR™ Valves and Shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the peritoneal cavity. The design enables the physician to noninvasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

The Medtronic StrataMR™ valves are implantable adjustable valves for the management of hydrocephalus. The valves and their associated catheters drain Cerebrospinal Fluid (CSF) from the ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. The Medtronic StrataMR™ valve incorporates a ball and cone pressure valve in series with a normally closed siphon control mechanism. Flow control is achieved and retrograde flow is prevented by combined resistance of the ball and cone and siphon control diaphragm. Before and after implantation, the pressure/flow characteristics of the Medtronic StrataMR™ valve can by modified by means of a magnetic adjustment tool.

The DUET™ EDMS is indicated for temporary draining and monitoring of cerebrospinal fluid (CSF) flow from the lumbar subarachnoid space in: - 1. Patients undergoing open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA) repair surgery. - 2. Patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia.

The Medtronic DUET™ External Drainage and Monitoring System (EDMS) that is the subject of this De Novo request is designed to drain and monitor cerebrospinal fluid (CSF) from the lumbar subarachnoid space. The DUET™ EDMS consists of the following: a green-striped patient connection line (pressure tubing) with an inner diameter of 0.075 ± 0.005 inches, an outer diameter of 0.124 ± 0.003 inches, and a total length of 60 inches (9), a patient line stopcock (10), a main system stopcock (8) that may be attached at two locations on the main panel, a drip chamber (4) with a drip chamber stopcock (5), a rotatable pressure scale (3), three latex-free needleless injection/CSF sampling sites (Figure 1b (IS-5), (IS-10) and (IS-11)) and a removable drainage bag (7) with approximate volumetric graduations and a hydrophobic microbial barrier air vent. There is a pole mount clamp (6) and a cord (12) with a cord lock (13) to enable independent suspension of the system, or to provide additional security when using the pole clamp as identified in Figure 1 below. It should be noted that the numbers in parentheses correspond with the numbers in Figure 1. The DUET™ EDMS are not long-term implants but are intended for limited external drainage of CSF. The drainage flow of CSF into the DUETTM EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. During use, an external lumbar catheter inserted into the lumbar subarachnoid space is connected to the DUET™ EDMS patient connection line. The CSF drains through the catheter, into the patient connection line and into the graduated drip chamber. CSF collects in the drip chamber, exits the bottom of the chamber via another connection line and is collected in a drainage bag. In the event that the patient may require administration of fluid directly into the lumbar subarachnoid space or CSF sampling is required, the DUET™ EDMS features injection/CSF sampling ports integrated into the patient connection line. The DUET™ EDMS is completely disposable. The DUET™ EDMS is recommended for use with the Clear-Site™ Laser Level (cleared under K984053) that is provided separately.

The Strata NSC Lumboperitoneal Shunt System provides continued cerebrospinal fluid (CSF) flow from the subarachnoid space into the peritoneal cavity. The Strata NSC Lumboperitoneal Valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus and may be used in the treatment of idiopathic intracranial hypertension (pseudotumor cerebri) when shunting is an option.

The Strata NSC Lumboperitoneal Valve and Shunt Systems are comprised of lumbar and peritoneal catheters, valves and accessories. The lumboperitoneal valve allows the physician to noninvasively adjust the pressure/flow performance level pre- and post-implantation using magnetic adjustment tools in order to address changing patient needs. The lumbar catheters are available in closed-tip and open-tip configurations and have length markers located at 5 cm intervals. A strain relief provides support to and lessens the potential of catheter kinking at the junction of the lumbar catheter to the valve and fixation tabs are provided to anchor catheters at the incisions.

The Medtronic ARES™ Antibiotic-Impregnated Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

The Medtronic ARES™ Antibiotic-Impregnated Catheters are manufactured using barium sulfate-filled silicone elastomer and are impregnated with clindamycin hydrochloride and rifampicin. ARES Antibiotic-Impregnated Ventricular Catheter The ARES ventricular catheter measures 23 cm in length, 0.13 cm in inner diameter, and 0.25 cm in outer diameter. Lengths are marked in 1 cm intervals starting from 3 cm to 15 cm from the catheter tip, thus enabling the surgeon to gauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 32 flow holes—four lines of eight holes spaced at 90° intervals around the catheter circumference. Components supplied with the ARES Ventricular Catheter include a pre-loaded stainless steel stylet and a Right Angle Clip, which is included to facilitate placement and use of the ventricular catheter. ARES Antibiotic-Impregnated Peritoneal Catheter The ARES peritoneal catheter measures 120 cm in length, 0.13 cm in inner diameter, and 0.25 cm in outer diameter. There are no length markers or wall slits on the catheter, and the tip is open ended. The catheter may be trimmed to the proper length.

The Strata NSC Lumboperitoneal Shunt System provides continued cerebrospinal fluid (CSF) flow from the subarachnoid space into the peritoneal cavity. The Strata NSC Lumboperitoneal Valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus.

PS Medical® Strata® NSC Lumboperitoneal Valve and Shunt System are designed for diversion of cerebrospinal fluid (CSF) from the lumbar subarachnoid space into the peritoneal cavity. The shunt's implantable components include: - Strata NSC Lumboperitoneal Valve ● - Lumbar Catheter, Closed Tip, Barium Impregnated . - Lumbar Catheter, Open Tip, Barium Impregnated . - Peritoneal Catheter, Small Lumen, Open End, Barium Impregnated . - Strain Relief . - Fixation Tabs .