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This website is intended for US audience only. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. QUICK VIEW. Photo: Courtesy of Business Wire. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. INDIGO System LIGHTNING Aspiration Tubing Intended Use If the cause cannot be determined, withdraw the device or system as a unit. Vascular Thrombectomy. Prior to use, please consult device labeling and instructions for use. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Do not reuse. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. UPC: Current Stock: This item is out of stock. It will reduce service life of the Penumbra ENGINE. gtag('js', new Date()); function gtag(){dataLayer.push(arguments);} Do not use in an oxygen rich environment. Lightning comes packaged with the Indigo CAT7 or CAT12. Use only waterbased solvents for cleaning. Do not use kinked or damaged devices. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/ guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. Do not use open or damaged packages. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Latest System Designed for Single Session Arterial Thrombus Removal News Contraindications There are no contraindications. Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. The procedure can be performed quickly,1 which is important for symptomatic patients. Sista A. Indigo aspiration system for acute pulmonary embolism. Due to our experience in such cases, sustained aspiration with the Indigo System CAT RX with Penumbra ENGINE has quickly become our frontline device, challenging the traditional method of manual aspiration in patients with thrombi and emboli in the coronary arteries. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Penumbra ENGINE Indication For Use The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Missouri Baptist Medical Center When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Warnings Initial angiogram of the right pulmonary artery showing pulmonary embolism. Do not use in an oxygen rich environment. . The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Copyright 2023 Penumbra, Inc. All rights reserved. The treatment of arterial and venous thrombus is challenging. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a A Penumbra CAT8 catheter was placed into the right upper lobe, right middle lobe, and right lower lobe, and aspiration with a separator was performed. The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Ballad CVA Heart & Vascular Institute Penumbra's high-performance aspiration catheters. Saxon RR, Benenati JF, Teigen C, et al. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial. Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Computer-Aided Aspiration comes packaged with CAT7 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. Copyright 2023 Penumbra, Inc. All rights reserved. The following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with high thrombus burden. If the cause cannot be determined, withdraw the device or system as a unit. Do not use kinked or damaged devices. These pages are not intended for patients or for members of the general public. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Equipment is not safe for MR use. Applicant. Do not resterilize or reuse. There were no cases of 30-day cardiovascular death or post procedural stroke. The pulmonary capillary wedge pressure is 10 mmHg. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . UPC: Current Stock: . Initial angiography revealed an occlusion of the distal RCA. Penumbra's not relying on software alone. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The CAT family of catheters is the foundation of Penumbra's Indigo System. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . INDIGO Aspiration System Intended Use Do not use kinked or damaged devices. The cat8 was kinked approximately 69. Use only water-based solvents for cleaning. Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. The Indigo Separator 4 is not intended for use as a guidewire. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Distal OD. Copyright 2022 Penumbra, Inc. All rights reserved. 3. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. gtag('js', new Date()); With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. INDIGO Aspiration Catheters and Separators: This press release features multimedia. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . [email protected] Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. Potential Adverse Events When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. BJC Cardiology Do not use open or damaged packages. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Los Angeles, California 2. Brandenton, Florida Copyright 2022 Penumbra, Inc. All rights reserved. Indigo Separator 4 is intended to be used with Indigo CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. Mathews SJ, Brown C, Kolski B, et al. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). Prior to use, please consult device labeling and instructions for use. Mathews SJ, Brown C, Kolski B, et al. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Warnings/Precautions The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. N Engl J Med. 3. The CAT family of catheters is the foundation of Penumbra's Indigo system. Chris Metzger, MD Do not block bottom air vents. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Maintain a constant infusion of appropriate flush solution. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Disclosures: None. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Not for use in the coronaries or the neurovasculature. Penumbra Aspiration Pump: The procedure time was short (median of 37 minutes)the shortest demonstrated so far in an investigational device exemption (IDE) trial on patients with pulmonary embolism. Precautions This content is not intended to offer professional medical advice. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. Penumbra Aspiration Pump: Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Throughout each case, Lightning provides procedural feedback via audio visual cues. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Potential Adverse Events The large aspiration lumen and highly trackable, low-profile design coupled with the power of the Penumbra ENGINE resulted in the successful removal of the emboli in one pass. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. If the cause cannot be determined, withdraw the device or system as a unit. Warnings/Precautions The canister is intended for single use only. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Created with Sketch. Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. function gtag(){dataLayer.push(arguments);} As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. Medical Director, Aortic Disease and Ischemic Limb Disease With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Separator 8, 150 cm Length, 0.072 in. 0 cm from the hub. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Use prior to the Use By date. If the cause cannot be determined, withdraw the device or system as a unit. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.