Search Results

The Reverse Medical Micro Vascular Plug (MVP-7, MVP-9) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Reverse Medical® MVP® Micro Vascular Plug System consists of a micro vascular occlusion plug that is attached to a composite delivery wire and is intended to be delivered to the treatment site through a catheter. The MVP occlusion plug is a selfexpandable, ovoid-shaped frame made from nitinol and incorporates a PTFE cover over the proximal portion of the ovoid. The plug device is secured at both ends with platinum marker bands. The proximal marker band is attached to a delivery wire that is used to push the plug device through a commercially available catheter to the intended treatment site. After satisfactory deployment of the plug device at the treatment site, the implant is detached from the delivery wire by rotating the wire counter clockwise.

The Reverse Medical® Corporation MVP® Micro Vascular Plug System is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Reverse Medical® MVP® Micro Vascular Plug System consists of a micro vascular occlusion plug that is attached to a composite delivery wire and is intended to be delivered to the treatment site through a catheter. The MVP occlusion plug is a selfexpandable, ovoid-shaped frame made from nitinol and incorporates a PTFE cover over the proximal portion of the ovoid. The plug device is secured at both ends with platinum marker bands. The proximal marker band is attached to a delivery wire that is used to push the plug device through a commercially available catheter to the intended treatment site. After satisfactory deployment of the plug device at the treatment site, the implant is detached from the delivery wire by rotating the wire counter clockwise.

The Reverse Medical Micro Vascular Plug (MVP-5) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.

The Reverse Medical Micro Vascular Plug (MVP) is a micro vascular occlusion device comprised of a detachable embolic plug attached to a composite delivery wire and designed for delivery via a microcatheter (0.027" ID). The MVP is a self-expandable, ovoid-shaped device made from Nitinol with an ePTFE partial cover. The device is secured at both ends with platinum marker bands. The Reverse Medical MVP is intended to reduce or occlude vascular blood flow of vessels having a diameter of 3.0 -5.0mm. The proximal marker band attaches to a delivery wire that pushes the device through a commercially available catheter to the intended treatment site. The Reverse Medical Detachment Box regulates detachment of the implant device from the delivery wire by electrolytic means during deployment, and monitors, detects, signals and measures the time of detachment. The Reverse Medical Cable Set - 275 cm length (Model RMCS – 2.75US) is provided sterile. The cable set connects to the Detachment Box through a bayonet type dual pin connector that ensures correct polarity. The Reverse Medical Cable Set and Detachment Box will be sold separately. One 9-volt battery and a sterile needle (20 G or 22 G) will also be needed for use with the Reverse Medical Micro Vascular Plug (MVP).

The Reverse Medical Microcatheter-027 is intended for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils.

The Reverse Medical Microcatheter-027 is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter-027 dimensions are included on the individual device labels. The Reverse Medical Microcatheter-027 inner lumen can accommodate guidewires up to 0.025 inches inner diameter to access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization. Each Reverse Medical Microcatheter-027 is provided with accessories, which include a shaping mandrel and peel away introducer within a Tyvek™ pouch. The shaping mandrel allows the catheter tip to be steam shaped by the physician for proper adjustment to the anatomy prior to use. Test data is presented in this submission for both the 027 and 021 Reverse Medical Microcatheters to support the inclusion of the shaping mandrel and the peel away introducer. The Reverse Medical Microcatheter-027 incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.

The Reverse Medical™ Micro Vascular Plug (MVP™) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.

The Reverse Medical Micro Vascular Plug (MVP) is a micro vascular occlusion device comprised of a detachable embolic plug attached to a composite delivery wire and designed for delivery via a microcatheter (0.021" ID). The MVP is a self-expandable, ovoid-shaped device made from Nitinol with an ePTFE partial cover. The device is secured at both ends with platinum marker bands. The Reverse Medical MVP is intended to reduce or occlude vascular blood flow of vessels having a diameter of 1.5 – 3.0mm. The proximal marker band attaches to a delivery wire that pushes through a commercially available catheter to the intended treatment site. The Reverse Medical Detachment Box regulates detachment of the implant device from the delivery wire by electrolytic means during deployment, and monitors, detects, signals and measures the time of detachment. The Reverse Medical Cable Set – 275 cm length (Model RMCS – 2.75US) is provided sterile. The cable set connects to the Detachment Box through a bayonet type dual pin connector that ensures correct polarity. The Reverse Medical Cable Set and Detachment Box will be sold separately. One 9-volt battery and a sterile needle (20 G or 22 G) will also be needed for use with the Reverse Medical Micro Vascular Plug (MVP).

The Reverse Medical Microcatheter is intended for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils.

The Reverse Medical Microcatheter is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter dimensions are included on the individual device labels. The Reverse Medical Microcatheter inner lumen can accommodate guidewires up to 0.018 inches in diameter to access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization. The Reverse Medical Microcatheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.

The Reverse Medical ReFlex™ Balloon Guide Catheter is indicated for use in facilitating and guidance of intravascular catheters into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

The ReFlex™ Balloon Guide Catheter is a flexible, variable stiffness composite catheter shaft has a hydrophilic coating to reduce friction during use. A compliant balloon is mounted on the distal end of the catheter. The ReFlex™ Balloon Guide Catheter dimensions are included on the individual device labels. The ReFlex™ Balloon Guide Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The proximal end of the ReFlex™ Balloon Guide Catheter has a bifurcated luer fitting to allow attachment of accessories and infusion of liquids through the system. The ReFlex™ Balloon Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.

The Reverse Medical RePort™ Guide Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

The RePort™ Guide Catheter System is a two-catheter system comprised of the RePort™ Sheath and the RePort™ Dilator. The RePort™ Sheath has a distal region which expands when the RePort™ Dilator is advanced. The RePort™ Guide Catheter System can be used with hydrophilic guidewires up to.038 inches in diameter to access the desired anatomy. The proximal ends of the RePort™ Sheath and the RePort™ Dilator have a luer fitting to allow attachment of accessories and infusion of liquids through the catheter is offered in various sizes to accommodate physician preferences and patient anatomy. A split sheath is provided in the package to provide support and facilitate the introduction of the RePort™ Sheath's distal expandable region into the catheter introducer sheath. The System is provided sterile, non-pyrogenic, and is intended for single use only.

The Reverse Medical ReFlex™ Guide Catheter is indicated for the introduction of interventional devices into the peripheral, and neuro vasculature.

The ReFlex™ Guide Catheter is a single lumen, flexible, variable stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The ReFlex™ Guide Catheter shaft is visible under fluoroscopy. The ReFlex™ Guide Catheter dimensions are included on the individual device label. The ReFlex™ Guide Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The proximal end of the ReFlex™ Guide Catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The ReFlex™ Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.

The Reverse Medical ReCruit™ Microcatheter is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and/or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

The Reverse Medical ReCruit™ Microcatheter consists of a flexible, tapered reinforced composite catheter with a braided mesh retrieval element attached to the distal region of the catheter. The inner lumen can accommodate a guidewire to aid in placement of the catheter. The catheter contains radiopaque markers to facilitate fluoroscopic visualization- a distal tip marker, markers at the proximal and distal end of the retrieval element, and circumferentially placed markers within the retrieval element. The retrieval element is deployed through the advancement of a guidewire or the ReAct™ stylet through the lumen to radially expand the retrieval element. The selection of guidewire sizes in accordance with device compatibility allows for guidewires to be used either for navigation and placement or for deployment of the element. The proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the catheter. The catheter is coated with a hydrophilic coating. The catheter is designed to be used with a guide catheter. The catheter is offered in various retrieval element sizes to accommodate physician preferences and patient anatomy. Each ReCruit™ Microcatheter is packaged with a ReAct™ stylet and torque device. The ReAct™ stylet is a stainless steel wire with a platinum tip that may be used to activate the ReCruit™ Microcatheter's retrieval element. The ReCruit™ Microcatheter can be used in vessel diameters ranging from 2mm to 4mm. Materials used in the Reverse Medical ReCruit™ Foreign Body Retrieval Microcatheter are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate device, and have historically been demonstrated to be both biocompatible and suitable for this use.