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). Do not use kinked or damaged devices. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Bradenton Cardiology Center/Manatee Memorial Hospital Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The pulmonary capillary wedge pressure is 10 mmHg. gtag('js', new Date()); The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Do not resterilize or reuse. Mechanical thrombectomy was performed. Do not use kinked or damaged devices. With a maximised inner diameter of 0.08 (2.1 mm) and a 7 French (2.3 mm) outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Do not use open or damaged packages. Prior to use, please consult device labeling and instructions for use. Applicant. Related Items. 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. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Possible complications include, but are not limited to, the following: INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use It will reduce the service life of the PENUMBRA ENGINE. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Units in stock: 1. The cat8 was kinked approximately 69. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Otherwise, this could result in degradation of the performance of this equipment. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. . 510 (k) Number. 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. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. INDIGO Aspiration System Intended Use In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. J Am Coll Cardiol. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Do not use open or damaged packages. 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 . Penumbra's high-performance aspiration catheters. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Aspiration or disruption of thrombus with traditional diminished syringe-based aspiration or other mechanical devices is difficult, often incomplete, and has been associated with high complication rates.1 Use of medical therapy, such as powerful anticoagulants and thrombolytics (ie, tissue plasminogen activator), may carry a high risk of bleeding.2 The Indigo System was designed to provide sustained aspiration with Penumbra ENGINE to effectively remove thrombus, while reducing the risk of bleeding complications.3 The Indigo System utilizes atraumatic catheters varying in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. Precautions 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. Distal emboli causing PDA occlusion after manual aspiration. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. function gtag(){dataLayer.push(arguments);} 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). N Engl J Med. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. The CAT family of catheters is the foundation of Penumbra's Indigo system. The product-specific content of this website is intended for use by healthcare professionals only. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Use prior to the Use By date. 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. Copyright 2023 Penumbra, Inc. All rights reserved. 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. Throughout each case, Lightning provides procedural feedback via audio visual cues. The patient remained on cangrelor with no need for tirofiban. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Precautions The device is intended or single use only. Penumbra, Inc. One Penumbra Place. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. 3. Do not use in an oxygen rich environment. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. 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. 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. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . The complaint has been evaluated. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Warnings INDIGO System LIGHTNING Aspiration Tubing Intended Use Indication For Use Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Engineered with neuro-tracking technology, CAT RX is designed to navigate tortuous anatomy and track to distal coronary vasculature while maintaining sustained mechanical aspiration with the Penumbra ENGINE. The CAT family of catheters is the foundation of Penumbras Indigo System. 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 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. 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. Ultrasound-guided access was obtained through the right femoral vein. Lightning 7 expands Penumbra's offering of the Indigo Aspiration System with Intelligent Aspiration for mechanical thrombectomy and is designed for single session arterial thrombus removal. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Initial angiography revealed an occlusion of the distal RCA. 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. The CAT family of catheters is the foundation of Penumbra's Indigo system. The removal of fibrous, adherent or calcified material (e.g. 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. Do not use kinked or damaged devices. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. These pages are not intended for patients or for members of the general public. 5 and 94. System Chair, Clinical Research Potential Adverse Events Figure 1. Use prior to the Use By date. 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.