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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

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Affirm 400 is a surgical microscope accessory used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery, comprising an excitation filter for blue spectral range between 390 nm and 420 nm and an observation filter for visible light with spectral range between 510 nm and 700 nm.

Affirm 400 is an accessory to the Class I Digital Surgical Microscope (DSM). Affirm 400 is a hardware and software which allows intraoperative viewing of suspected grade III and IV gliomas under fluorescence with the 5-ALA optical imaging agent. Affirm 400 is composed of optical filters: the "Excitation" filter and the "Emission" filter. The Excitation filter is designed to filter light between 390-420 nanometers. The Emission filter is designed to filter light between 510 – 700 nanometers. The use of a suitable detection system allows for visualization of surgical interventions. The emitted light is then captured by the optics of the digital microscope, passed through filters to remove unwanted wavelengths of light, and finally detected by the image sensors. This detected signal is then projected on a monitor enabling the surgeon to view the magnified image. The Affirm 400 includes installation of a software license that facilitates use of the accessory. After the software license is installed, the user has the option to switch from the normal white light mode of the surgical microscope to the Affirm 400 mode.

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The NeuroSpan Bridge is indicated for the repair of peripheral nerve discontinuities where a tensionless repair can be made (i.e., by flexion of the extremity).

The NeuroSpan Bridge is a biodegradable micro-channeled implant for the repair of peripheral nerve discontinuities. The NeuroSpan Bridge provides a protective environment for peripheral nerve repair after injury, and is designed to be an interface between the two transected nerve stumps in order to provide a bridge for axonal growth across the nerve gap.

The NeuroSpan Bridge is flexible while being strong enough to hold sutures. The NeuroSpan Bridge is made from polycaprolactone (PCL) and features overhangs on both ends for suturing, with marks showing the overhang depth. The overhang allows the surgeon to place the nerve stump with apposition to the internal microchannel structure and suture without damaging it. The NeuroSpan Bridge has multiple channels throughout the device for axon growth. The NeuroSpan Bridge is provided sterile, for single use, and in multiple diameter and length variations.

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Intended Use / Indications for Use

Over-the-counter use:

actiTENS Mini is intended to be used as:

Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:

• Symptomatic relief and management of chronic, intractable pain
• Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
• Relief of pain associated with arthritis

Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode.

Prescription use:

actiTENS Mini is intended to be used as:

Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:

• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
• Relief of pain associated with arthritis

Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode.

Electrical Muscle Stimulation (EMS), used for the following indications:

• Temporary relaxation of muscle spasms
• Prevent or retard disuse atrophy
• Increase of local blood flow in the treatment area
• Re-educate muscles
• Maintain or increase the range of motion
• Prevention of venous thrombosis of the calf muscles immediately after surgery

Program P9 corresponds to EMS mode.

The actiTENS mini is a connected medical device for transcutaneous electrical nerve stimulation (TENS) intended to treat pain in adults. It also contains an electrical muscle strengthening (EMS) program. It is intended for people over 22 years of age with unimpaired intellectual abilities. The actiTENS mini is fixed directly on the body using a fastening accessory. It adapts to the shape of the body with its flexible design. The actiTENS mini can be used discreetly during daily activities.

The EIG (electrical impulse generator) generates electrical impulses that are diffused in the body through skin electrodes connected to one or two channels via cables available in various lengths. Managing the EIG is done by means of the actiTENS Mobile App that allows users to control the stimulation session by choosing: a stimulation program, the number of channels used, the stimulation intensity for each channel and the stimulation duration.

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The Toro 88 Superbore Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Toro 88 Superbore Catheter is a variable stiffness, single lumen catheter designed to introduce interventional devices into the vasculature. The catheter shaft design includes stainless steel and nitinol wires and polymers of varying durometers. The catheter incorporates an internal lubricious liner to facilitate its advancement over a steerable guidewire or microcatheter. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a hub with Luer lock. The catheter is supplied sterile, for single use only.

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As part of the Esperance pHLO Aspiration System, the Esperance pHLO Aspiration Catheter with a compatible aspiration pump and the Esperance Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

The device is supplied as a kit consisting of a single Esperance® pHLO Aspiration Catheter, the Esperance Aspiration Tubing Set, and an introducer sheath, which combined comprise the Esperance® pHLO Aspiration System.

The Esperance® pHLO Aspiration Catheter is single lumen, flexible, variable stiffness composite catheter. A hub is attached to the proximal end, facilitating attachment of accessories, and the passage of devices into the inner lumen of the catheter, and connection to ancillary devices such as a vacuum source. A polymer sleeve is also attached to the hub and provides a gradual reduction in stiffness from the hub to the catheter shaft, in order to act as a strain relief.

A radiopaque marker is located approximately 0.6mm from the distal end of the catheter to allow visibility under fluoroscopy. Beyond the radiopaque marker comprises the soft atraumatic tip of the catheter. The following components: inner liner(s), braid, coil and polymer jackets are a part of the internal construction of the catheter. The distal 100cm of the catheter's external surface has a hydrophilic coating for increased lubricity during use. The Esperance pHLO Aspiration Catheter is offered with effective lengths of 125cm and 135cm with an outer diameter (OD) of 6F (0.083", 2.1mm) and an inner diameter (ID) of 0.071" (1.8mm).

The Esperance® pHLO Aspiration System is a non-active, surgically invasive device intended for short term use within the neurovasculature. The finished catheter is supplied sterile in a hoop, pouch and shelf carton configuration complete with an introducer sheath, aspiration tubing, and Directions for Use (DFU).

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METICULY Patient-specific titanium mesh implant is a device that is designed individually for each patient. This device is indicated for reconstruction of bony defects resulting from selective trauma of the cranial and craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer) during cranial and craniofacial surgery and reconstructive procedures.

METICULY Patient-specific titanium mesh implant is a device designed individually to replace each patient's bony defects (bony voids and/or bone deformities) in the cranial and/or craniofacial skeleton. The craniofacial skeleton comprises the frontal bone, temporal bone, sphenoid bone, parietal bone, occipital bone, supraorbital process and vomer bone. This patient-specific device is intended to be used with titanium screws. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The FDA-cleared commercially available titanium screws that can be used with the subject devices include the Jeil Medical's LeForte Neuro System screws (K141452), the Titanium miniplate system (K951690) and Micro titanium plate system (K951688). The surgeon approves the design of the mesh implant prior to fabrication of the implant device.

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