[email protected] Return all damaged devices and packaging to the manufacturer/distributor. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Indigo System | Computer-Aided Mechanical Aspiration. Possible complications include, but are not limited to, the following: [email protected] QUICK VIEW. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). Waqas R. Qureshi, MD, MS We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Copyright 2023 Penumbra, Inc. All rights reserved. The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Gus Theodos, MD, FACC, FSCAI $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . [email protected]; @gtheodosmd Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. The cerebral vasculature The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Do not use open or damaged packages. Figure 3. The device is intended for single use only. Tip directionality for circumferential aspiration, Live feedback during procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposablePenumbra ENGINE Canister. 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. Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX Final angiogram showing resolution of extensive thrombus burden. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Worcester, Massachusetts 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. Copyright 2022 Penumbra, Inc. All rights reserved. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Do not use in an oxygen rich environment. Warnings/Precautions The canister is intended for single use only. PENUMBRA: CAT3 - westcmr.com Do not use in oxygen rich environment. If the cause cannot be determined, withdraw the device or system as a unit. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. The product-specific content of this website is intended for use by healthcare professionals only. Precautions The device is intended for single use only. 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. Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Learn more about Lightning. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. S. Jay Mathews, MD, MS, FACC 5, 19. The complaint indicated that the cat8 was kinked during the procedure. Mathews SJ, Brown C, Kolski B, et al. Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. BJC Cardiology INDIGO Aspiration System Intended Use Do not reuse. Indigo System | Penumbra Inc Do not use kinked or damaged devices. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Figure 1. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. function gtag(){dataLayer.push(arguments);} It will reduce the service life of the PENUMBRA ENGINE. Figure 2. Control angiography immediately after thrombectomy demonstrated restored patency . Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . The Indigo System met its efficacy and safety endpoints by reducing right-to-left ventricle (RV/LV) ratio at 48 hours by 27.3% (mean ratio reduction, 0.43; 95% confidence interval, 0.380.47; P < .0001) and had a low major adverse event of 1.7% (2/119). [email protected] The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Ballad CVA Heart & Vascular Institute If repositioning of the INDIGO CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. Final angiographic result of SVG. The results may vary depending on a variety of patient specific attributes. Units in stock: 1. Figure 3. The atraumatic, low-profile design of CAT RX allowed for ease of deliverability through the freshly placed stent into the PDA when the patient was in critical condition. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 0, and 37. Contraindications There are no known contraindications. Brandenton, Florida Penumbra Indigo System | Vascular Thrombectomy Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. The INDIGO Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. Tip directionality for circumferential aspiration, Live feedback during procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposablePenumbra ENGINE Canister. Circulation. Do not use in an oxygen rich environment. Ultrasound-guided access was obtained through the right femoral vein. Do not resterilize or reuse. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Not for use in the coronaries or the neurovasculature. 2. Related Items. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Alameda, CA 94502. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Los Angeles, California This warranted the need for further innovation in the field of acute coronary syndrome.2 The goal of the Indigo System CAT RX mechanical aspiration system powered by the Penumbra ENGINE is to provide sustained aspiration for the duration of the procedure with enhanced deliverability to navigate tortuous anatomy and track to the distal coronary vasculature. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. 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. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the Penumbra ENGINE as they can interfere with and result in degradation of the performance of the equipment. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Do not use in oxygen rich environment. The procedure was completed with the same catheter. Throughout each case, Lightning provides procedural feedback via audiovisual cues. SVG occlusions can be challenging to resolve using traditional treatment modalities. Penumbra ENGINE Indication For Use There are no contraindications. To prevent fire or shock hazard, use a replacement power cord of equal rating. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Throughout each case, Lightning provides procedural feedback via audio visual cues. Penumbra, Inc. One Penumbra Place. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. 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. 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. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. The INDIGO Aspiration System is intended to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature and for the treatment of pulmonary embolism. function gtag(){dataLayer.push(arguments);} Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. TIMI 3 flow was achieved in 88% of cases. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. INDIGO System LIGHTNING Aspiration Tubing Intended Use Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Mechanical Thrombectomy. Disclosures: Consultant to Penumbra, Inc. An 83-year-old woman transferred from an outside hospital presented with acute shortness of breath, was hypotensive, and was intubated. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. window.dataLayer = window.dataLayer || []; 1. The CAT family of catheters is the foundation of Penumbra's Indigo System. Use prior to the Use By date. Figure 2. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia/fibrillation; arteriovenous fistula; death; device malfunction; distal embolization; emergent surgery; false aneurysm formation; hematoma, hemorrhage, or blood loss at access site; hematoma, hemorrhage, or blood loss; hypotension; inability to completely remove thrombus or control blood flow; infection; ischemia; kidney damage from contrast media; myocardial infarction; neurological deficits including stroke; respiratory failure; thromboembolic events; vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation). MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 Use prior to the Use By date. Tareq Kass-Hout. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Latest System Designed for Single Session Arterial Thrombus Removal News System Chair, Clinical Research PENUMBRA: SEP8 - Westcmr.com The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Final angiogram with complete TIMI 3 flow after the use of CAT RX. Contraindications Do not use open or damaged packages. 2: Add 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 . The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Catheters & Separators. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Rethinking Thrombus Removal With the Indigo System: Introducing The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Copyright 2023 Penumbra, Inc. All rights reserved. PENUMBRA: CAT6 - WestCMR Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. The product-specific content of this website is intended for use by healthcare professionals only. Figure 2. 2. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Applicant. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Aspiration Tubing Intended Use N Engl J Med. Figure 1. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Potential Adverse Events Otherwise, this could result in degradation of the performance of this equipment. Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. 5, 21. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Warnings These pages are not intended for patients or for members of the general public. Return all damaged devices and packaging to the manufacturer/distributor. Use prior to the Use By date. function gtag(){dataLayer.push(arguments);} No conversations found. Possible complications include, but are not limited to, the following: Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary chronic clot, atherosclerotic plaque) Jawairia Sahar K. Mirza, MBBS A 65-cm 8-F Destination sheath (Terumo Interventional Systems) was advanced into the right pulmonary artery, first over a telescoping balloon tip catheter and stiff angle Glidewire (Terumo Interventional Systems). 2023 Bryn Mawr Communications II, LLC. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. [email protected] Please email [email protected] or call us at 877-663-8686 and we will try to locate the product with our suppliers. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. 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. Do not re-infuse blood or fluid from the canister back into the patient. After one pass with mechanical thrombectomy using CAT RX, the thrombus was removed and flow was restored to the pedal arch via the plantar posterior tibial artery (Figure 2 and Figure 3). Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. 3D, 3D Revascularization Device, ACE, Artemis, BENCHMARK, CAT, Indigo, LANTERN, Lightning, MAX, Neuron, Neuron MAX, Penumbra Coil 400, Penumbra ENGINE, Penumbra P logos, Penumbra System, Penumbra SMART COIL, POD, PX SLIM, Ruby, Select, Separator, Velocity, and WAVE are all registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. CAT7 and CAT12 are the next generation of the Indigo System Catheters. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Worcester, Massachusetts The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 0 cm from the distal tip. The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a . Figure 2. As part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. Power aspiration with CAT RX has allowed us to successfully remove thrombus in patients presenting with acute coronary syndrome, establishing quick distal reperfusion and also visualization of the underlying stenosis. No modification of this equipment is allowed. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Jolly SS, Cairns JA, Lavi S, et al. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization Indication For Use 1. Maintain a constant infusion of appropriate flush solution. Penumbra's CAT family of catheters is engineered to be robust, trackable, atraumatic, and well suited to the peripheral anatomy where clots can form in long segments. Saxon RR, Benenati JF, Teigen C, et al.
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