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The DABRA Excimer Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

The Ra Medical Systems' DABRA™ Laser Catheter Model 2.0 and RA-308 Excimer Laser is composed of a reusable Excimer laser light source and e-beam sterilized single use catheter. The laser light is generated by a software-controlled 308nm Excimer source and directed to the catheter through a lens. The fiber and the fluid direct the ultraviolet laser energy from the laser light source to the tip of the catheter. The catheter is connected to the laser for the procedure, and then inserted into the patient's vasculature, allowing the physician to target the laser energy to the lesion. The laser energy photoablates the lesion creating a lumen that permits blood flow. The lumen can be used for other interventional treatment devices. The system is designed to be used in a catheterization laboratory. This setting includes fluoroscopy devices, injecting devices, patient monitoring devices, a table for the patient, and personnel to assist the physician in performing the treatment.

The DABRA Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

The Ra Medical Systems' DABRA™ Laser Catheter model 101 and RA-308 Excimer Laser is composed of an Excimer laser light source and gamma sterilized single use catheter consisting of an extruded fluorinated ethylene propylene (FEP) tube coated on the inner diameter with an amorphous fluoropolymer thin film resulting in total internal reflection of 308 nm light capped at each end by optical fiber (fused silica). The laser light is generated by a software-controlled 308nm Excimer source though a discharge excitation process within a gas filled resonating cavity. The light is directed to the catheter through a lens. The fiber and the fluid use total internal reflection to direct the ultraviolet laser energy from the laser light source to the tip of the catheter. The catheter is connected to the laser for the procedure, and then inserted into the patient's vasculature along the length of a previously inserted guide catheter, support catheter, quiding sheath, or introducer sheath allowing the physician to target the laser energy to the lesion. The laser energy photoablates the lesion creating a lumen that permits blood flow. The lumen can be used for other interventional treatment devices. The system is designed to be used in a catheterization laboratory. This setting includes fluoroscopy devices, injecting devices, patient monitoring devices, a table for the patient, and personnel to assist the physician in performing the treatment.

The DABRA Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

The Ra Medical Systems' DABRA Laser System™ is composed of a laser light source and catheter consisting of optically conducting fluid encased in medical grade tubing enclosed by an optical window on either end. The tip and the fluid conduct the ultraviolet laser energy from the laser light source to the distal tip of the catheter. The laser light is generated by a 308nm excimer source. The catheter is connected to the laser for the procedure, and then inserted into the patient's vasculature, allowing the physician to target the laser energy to a blockage or lesion. Patient contacting parts of the device are the distal tip (titanium), the distal tip window (glass), the glue for the distal tip (epoxy), and the catheter tube (FEP). These parts are limited (<24 hours) blood contact. The laser energy photoablates the lesion material creating a lumen that permits blood flow, and allows access for other interventional treatment devices, such as balloons. The system is designed to be used in a catheterization laboratory. The candidates for this type of laser treatment are people who have blockages in their leg arteries that completely obstruct flow (chronic total occlusions). Flow obstruction of this type causes pain, wounds that do not heal, gangrene and ultimately limb amputation.

The PHAROS Excimer Laser will be indicated for use for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.

RA Medical Systems, Inc.'s PHAROS Excimer Laser is a medical laser that is a self-contained UV laser light source that emits a wavelength of 308 nm. The PHAROS Excimer Laser utilizes a XeCl gas mixture to generate an operator-selected dose and targetspecific UV light. The laser dose is activated by a footswitch with the therapeutic radiation emitting from a handheld device. The laser operation is key controlled and is contained within an interlocked housing.

The Tiara Medical Systems SNAPP-X is intended to be used with continuous positive airway pressure devices (CPAP), operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The SNAPP-X is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP-X is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed

The Tiara Medical Systems SNAPP™ -X Soft Nasal Accessory for Positive Pressure is a nasal cannula with inserts intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure). It provides a seal such that positive pressure from a positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild detergent such as Ivory® dishwasher liquid and water. The cleaning process does not require disassembly. The device consists of latex-free silicone air delivery tubes connecting a polycarbonate Wye adapter / swivel with a latex-free silicone soft, resilient nasal inserts which form a seal with the nostrils. The device connects to a conventional air delivery hose between itself and the positive airway pressure source via a standard 22 mm polycarbonate fitting on the combination Wye adapter / swivel. The built in vent slots are molded into the underside of the nasal insert body to direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use. The SNAPP-X Headgear is available in multiple sizes to fit a broad range of facial structures, and attaches to the SNAPP-X via slots molded into the nasal insert body.

The Tiara Medical Systems FULL ADVANTAGE™ Full Face Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure) for the treatment of adult obstructive sleep apnea.

The Tiara Medical Systems Full Advantage™ Full Face Mask is an externally placed mask covering the nose and mouth of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and mouth when either or both are open. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process requires limited disassembly. The mask consists of a molded multiple sized polycarbonate shell with a soft, resilient silicone skincontacting cushion seal which conforms to the patient's facial features. A silicone forehead pad attaches to a polycarbonate frame and is adjustable to suit patient comfort. The mask connects to a conventional air delivery hose between the mask and the positive airway pressure source via a standard 22 mm polycarbonate elbow/swivel/valve assembly. The elbow/swivel/valve assembly attaches to the front of the mask with a polyethylene split "c" clip. The built in vent ports are located on the elbow/swivel/valve assembly to provide a continuous air leak to prevent rebreathing of deadspace CO2, direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent ports also allow the patient to exhale normally and do not interfere with the other performance requirements of the vent ports may be visually checked for obstruction prior to use. The elbow/swivel/valve assembly also includes a built in Anti-Asphyxia Valve which allows the patient to continue to breathe fresh air in the event of positive air pressure device failure or output deterioration, or delivery hose kinking/obstruction.

The Tiara Medical Systems SNAPP is intended to be used with continuous positive airway pressure devices (CPAP), operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The SNAPP is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.

The Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure is a nasal cannula with inserts intended to be used with positive anway pressure devices such as CPAP (Continuous Possure). It provides a seal such that positive pressure from a positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process does not require disassembly. The device consists of latex-free silicone air delivery tubes connecting a polycarbonate Wye adapter / swivel with a latex-free silicone soft, resilient nasal inserts which form a seal with the nostrils. The device connects to a conventional air delivery hose between itself and the positive airway pressure source via a standard 22 mm polycarbonate fitting on the combination Wye adapter / swivel. The built in vent slots are molded into the underside of the nasal insert body to direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use. The SNAPP Headgear is available in three sizes to fit a broad range of facial structures, and attaches to the SNAPP via slots molded into the nasal insert body.

The Tiara Medical Systems Advantage II Nasal Mask is intended to be used with continuous positive airway pressure devices (CPAP); operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.

The Tiara Medical Systems Advantage II™ Nasal Mask is an externally placed mask covering the nose such that positive pressure from a positive pressure source is directed of the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process requires limited disassembly. The mask consists of a molded polycarbonate shell with a soft, resilient silicone skin-contacting rille mask conforms to the patient's facial features. A silicone forehead cushion is available for added comfort. The mask connects to a conventional air delivery hose between the mask and the positive airway pressure source the mask with a polyethylene split "c" ring. The built in vent slots (2) are located attacres to the from of the make with a perfect's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use. Canadation access is available in a variety of sizes to fit a broad range of facial structures, and attaches to the mask via slots contained within the shell.

The Tiara Medical Systems Advantage™ Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 3 cmH2O for the treatment of adult obstructive sleep apnea.

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The TIARA MEDICAL SYSTEMS INC. AirPilotMask ™ Nasal Mask is a non-sterile, clean, single patient reusable mask intended to be used with CPAP (continuous airway pressure) devices for the treatment of adult obstructive sleep apnea.

TIARA MEDICAL SYSTEMS INC. AirPilotMask™ Nasal Mask