cat8 penumbra catheter cat8 penumbra catheter

The patient remained on cangrelor with no need for tirofiban. SVG occlusions can be challenging to resolve using traditional treatment modalities. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. 5, 19. 2. 1. Copyright 2022 Penumbra, Inc. All rights reserved. Do not re-infuse blood or fluid from the canister back into the patient. Director of Cardiac Catheterization Lab, PERT & Structural Heart K180412. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. 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 . N Engl J Med. Gus Theodos, MD, FACC, FSCAI 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Circulation. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. . Not for use in the coronaries or the neurovasculature. Throughout each case, Lightning provides procedural feedback via audiovisual cues. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Control angiography immediately after thrombectomy demonstrated restored patency . Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. After one pass with CAT RX, the initial occlusion was removed. Maintain a constant infusion of appropriate flush solution. The CAT family of catheters is the foundation of Penumbra's Indigo system. With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; and Suhail Dohad, MD, FACC. . Copyright 2023 Penumbra, Inc. All rights reserved. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. If the cause cannot be determined, withdraw the device or system as a unit. Penumbra ENGINE Intended Use Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Contraindications Not for use in the coronaries or the neurovasculature. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Brandenton, Florida Indigo Disposable Separator 8, 150 cm Length, 0.072 in. INDIGO Aspiration System Indication for Use Return all damaged devices and packaging to the manufacturer/distributor. In 2014, Penumbra broke into the peripheral thrombectomy space with the release of the first Indigo System catheters, the 5-F CAT5 catheter and the 3-F CAT3 catheter (Penumbra, Inc.). Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Do not use open or damaged packages. Potential Adverse Events BJC Cardiology QUICK VIEW. Created with Sketch. Figure 1. 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 . Enter your email address and we will contact you. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Precautions 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. 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. 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. Precautions The device is intended for single use only. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Los Angeles, California This is potentially more effective than diminished syringe-based aspiration. Pinterest; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm Penumbra System) Model #: CAT8XTORQ115KIT OEM: Penumbra System Expiration Date: 2022 Size : 8Fr x 115cm . . There are no contraindications. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. INDIGO Aspiration Tubing: The Indigo Separator 4 is not intended for use as a guidewire. 0, 23. Saint Louis, Missouri Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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 CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. 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. Do not use open or damaged packages. right-arrow 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. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Initial angiography revealed an occlusion of the distal RCA. 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. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. 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 in oxygen rich environment. Equipment is not safe for MR use. Copyright 2023 Penumbra, Inc. All rights reserved. Next Article Jawairia Sahar K. Mirza, MBBS PENUMBRA ENGINE Intended Use A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Distal emboli causing PDA occlusion after manual aspiration. This website is intended for US audience only. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. 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. 3. Use prior to the Use By date. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. Manual aspiration suffers from diminished aspiration force as fluid fills in the syringe, potentially resulting in systemic embolization during catheter removal, as shown in the TOTAL trial published in 2015 (Figure 1).1 Subgroup analysis of patients with high thrombus burden was explored that highlighted the potential for improved outcomes. Do not resterilize or reuse. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Do not block bottom or back air vents. 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; Do not resterilize or reuse. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. 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 cerebral vasculature 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). Her heart rate was 110 beats per minute, elevated troponin levels at 4.5 ng/mL, and elevated brain natriuretic peptide at 1,164 pg/mL. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Photo: Courtesy of Business Wire. INDIGO Aspiration Catheters and Separators: 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. Lightning comes packaged with the Indigo CAT7 or CAT12. 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. CAT RX has allowed us to rethink how we approach these occluded SVGs. 2: Add Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. If the cause cannot be determined, withdraw the device or system as a unit. The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. Penumbra ENGINE Intended Use The Indigo System utilises the Penumbra ENGINE aspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Separator 8, 150 cm Length, 0.072 in. 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. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. It will reduce service life of the Penumbra ENGINE. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. gtag('js', new Date()); Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. 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). Learn more about Lightning. Mechanical Thrombectomy. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. 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. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. The CAT family of catheters is the foundation of Penumbra's Indigo System. Worcester, Massachusetts Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Maintain a constant infusion of appropriate flush solution. Potential Adverse Events Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. TIMI 3 flow was achieved in 88% of cases. PENUMBRA ENGINE Indication for Use J Vasc Interv Radiol. PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: 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. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Do not use kinked or damaged devices. Do not use kinked or damaged devices. St. Joseph Hospital INDIGO Aspiration System Intended Use 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. 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. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Indigo System CAT RX tracking through the distal posterior tibial artery. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI. Cedars Sinai Medical Center The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Catheters & Separators. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. The Indigo System CAT RX with Penumbra ENGINE is an invaluable tool that is easy to set up and can provide rapid thrombectomy and immediate reperfusion. The patient underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. 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. Related Items. Penumbra's not relying on software alone. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. UPC: Current Stock: This item is out of stock. $399.00 EACH. The pain became more intense and constant, so he presented to the ED. 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. Additional Details. 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. Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Available in a selection of sizes, the CAT family can provide access to distal peripheral . The INDIGO SEPARATOR 4 is not intended for use as a guidewire. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The CAT family of catheters is the foundation of Penumbra's Indigo System. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Penumbra, Inc. One Penumbra Place. Maintain a constant infusion of appropriate flush solution. Warnings/Precautions For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Waqas R. Qureshi, MD, MS After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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. Use prior to the Use By date. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. No modification of this equipment is allowed. function gtag(){dataLayer.push(arguments);} Randomized trial of primary PCI with or without routine manual thrombectomy. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 5, 21. Equipment is not safe for MR use. The system uses Penumbra's RED reperfusion catheters. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. Final angiogram after stent placement showing resolution of underlying disease. chronic clot, atherosclerotic plaque) Indigo Aspiration System Intended Use The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. We presented our initial experience at the American College of Cardiologys (ACC) 68th Annual Scientific Session, which showed promising results for mechanical power aspiration for thrombus removal during percutaneous intervention using CAT RX.3 This retrospective case series included 59 patients from four institutions around the United States. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. The complaint has been evaluated. 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. The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. Penumbra ENGINE Indication For Use 0 cm from the distal tip. 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.