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. 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. Director, Structural Heart
Jolly SS, Cairns JA, Lavi S, et al. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. 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. gtag('js', new Date()); 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). Maintain a constant infusion of appropriate flush solution. Mechanical Thrombectomy. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). right-arrow Initial angiogram showing high thrombus burden in the RCA. 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. Mathews SJ, Brown C, Kolski B, et al. This website is intended for US audience only. Indication For Use Copyright 2023 Penumbra, Inc. All rights reserved. There was partial improvement of flow, but total occlusion remained. 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 ENGINE Intended Use With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Use only water-based solvents for cleaning.
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CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The complaint indicated that the cat8 was kinked during the procedure. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. This ability of lobar thrombectomy likely allowed EXTRACT-PE to be the first endovascular IDE, pulmonary embolism trial that has reported statistically significant reduction in on-table systolic pulmonary artery pressures. INDIGO Aspiration System Intended Use Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. The patient remained on cangrelor with no need for tirofiban. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Do not use open or damaged packages. The procedure was completed with the same catheter. These pages are not intended for patients or for members of the general public. Contraindications There are no contraindications. 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. Enter your email address and we will contact you. The device is intended for single use only. It will reduce service life of the Penumbra ENGINE. 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. Alameda, CA 94502. The penumbra cat8 indigo system (cat8) was kinked approximately 4. The cerebral vasculature Use prior to the Use By date. Final angiographic result of SVG. CAT RX has allowed us to rethink how we approach these occluded SVGs. Jolly SS, Cairns JA, Yusuf S, et al. Do not re-infuse blood or fluid from the canister back into the patient. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. This website is intended for US audience only. 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 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 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. 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. Available in a selection of sizes, the CAT family can enable access to distal peripheral vessels of the upper and lower extremities, including below the knee. Figure 1. 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. Precautions Director of Cardiac & Peripheral Cath Lab
Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Ballad CVA Heart & Vascular Institute
chronic clot, atherosclerotic plaque) Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. 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. INDIGO Aspiration Catheters and Separators: Director of Cardiac Catheterization Lab, PERT & Structural Heart
Copyright 2022 Penumbra, Inc. All rights reserved. Further evaluation of the returned device revealed kinks in the catheter shaft. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Do not use in oxygen rich environment. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Available in a selection of sizes, the CAT family can enable access to distal peripheral vessels of the upper and lower extremities, including below the knee. 2018;29:92-100. These pages are not intended for patients or for members of the general public. Do not use kinked or damaged devices. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The CAT family of catheters is the foundation of Penumbra's Indigo system. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. 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. Equipment is not safe for MR use. 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 Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. function gtag(){dataLayer.push(arguments);} 0 cm from the distal tip. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Medical Director, Aortic Disease and Ischemic Limb Disease
Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). SVG occlusions can be challenging to resolve using traditional treatment modalities. Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . Indication For Use 22. Equipment is not safe for MR use. Do not use in oxygen rich environment. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. 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 Aspiration Tubing is a sterile aspiration tubing component of the INDIGO Aspiration System and 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. Do not re-infuse blood or fluid from the canister back into the patient. 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. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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). gtag('js', new Date()); Available in a selection of sizes, the CAT family can provide access to distal peripheral . Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. There were no cases of 30-day cardiovascular death or post procedural stroke. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Applicant. 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. Control angiography immediately after thrombectomy demonstrated restored patency . Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The INDIGO Aspiration Tubing: Distal posterior tibial artery emboli occlusion. UPC: Current Stock: This item is out of stock. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Because the patient was not a candidate for thrombolysis, the decision was made to intervene with the Indigo System CAT8XTORQ115 and SEP 8, which were advanced sequentially into the right then left pulmonary artery. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Prior to use, please consult device labeling and instructions for use. This is potentially more effective than diminished syringe-based aspiration. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Figure 2. 3. Related Items. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Final angiogram after stent placement showing resolution of underlying disease. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. 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. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. 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. INDIGO Aspiration System Indication for Use Penumbra Aspiration Pump: Potential Adverse Events 0 cm from the hub. minimalism: a documentary about the important things transcript; cat8 penumbra catheter; i 75 road construction cincinnati; tocaya west hollywood; best places to live in alabama near the. Warnings/Precautions The canister is intended for single use only. Do not use open or damaged packages. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Prior to use, please consult device labeling and instructions for use. 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 . Possible complications include, but are not limited to, the following: 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. This content is not intended to offer professional medical advice. 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. Otherwise, this could result in degradation of the performance of this equipment. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. 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. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Only use replacement fuse with correct rating (see Table 1 for fuse rating). The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Possible complications include, but are not limited to, the following: She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. 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. Disclosures: Consultant to Penumbra, Inc. A 75-year-old woman with a history of diabetes, hypertension, and dyslipidemia presented with Rutherford class 5 critical limb ischemia (CLI) due to a nonhealing ulcer. 2015;372:1389-1398. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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. 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. Penumbra's LANTERN Delivery Microcatheter integrates a highly trackable 2.6 F microcatheter with a high-flow lumen to facilitate confident delivery of Ruby Coil, POD, and Packing Coil even in tortuous anatomy. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. University of Massachusetts Medical School
The Swan-Ganz catheter was exchanged over a long V18 wire. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Giri J, Sista AK, Weinberg J, et al. 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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. PENUMBRA ENGINE Intended Use Suhail Dohad, MD, FACC
Potential Adverse Events Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to . The CAT family of catheters is the foundation of Penumbra's Indigo System. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Warnings gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. . Do not use kinked or damaged devices. 1. 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. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 Missouri Baptist Medical Center
Return all damaged devices and packaging to the manufacturer/distributor. Otherwise, this could result in degradation of the performance of this equipment. Flow through left circumflex artery post-CAT RX. 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.