cat8 penumbra catheter

Initial angiogram showing high thrombus burden in the left circumflex artery. Orange, California 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. 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. 2017;377:2240-2252. Applicant. All Rights Reserved Privacy Policy, 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; Suhail Dohad, MD, FACC. Tareq Kass-Hout. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. To prevent fire or shock hazard, use a replacement power cord of equal rating. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Device Name. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Director of Cardiac & Peripheral Cath Lab Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. 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. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. UMassMemorial University Campus Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. These types of burns heal withing 5 or 6 days without permanent scarring. 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. CAT RX has allowed us to rethink how we approach these occluded SVGs. 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 Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Do not resterilize or reuse. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems This content is not intended to offer professional medical advice. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. 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. 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. 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. 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). Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Copyright 2022 Penumbra, Inc. All rights reserved. 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. Mechanical thrombectomy was performed. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Equipment is not safe for MR use. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. The canister is intended for single use only. 1. Randomized trial of primary PCI with or without routine manual thrombectomy. The Indigo Aspiration System is comprised of several devices: The Indigo System may be used as a first-line approach or rescue therapy for arterial and venous thrombotic events. The CAT familyof catheters is the foundation of Penumbras Indigo System. Medical Director, Aortic Disease and Ischemic Limb Disease The CAT family of catheters is the foundation of Penumbra's Indigo System. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Penumbra ENGINE Intended Use To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. PENUMBRA ENGINE Intended Use It will reduce the service life of the PENUMBRA ENGINE. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Distal emboli causing PDA occlusion after manual aspiration. 0, 23. $399.00 EACH. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Return all damaged devices and packaging to the manufacturer/distributor. There were no cases of 30-day cardiovascular death or post procedural stroke. TIMI 3 flow was achieved in 88% of cases. 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 . 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). The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 2018;29:92-100. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Maintain a constant infusion of appropriate flush solution. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. University of Massachusetts Medical School If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. 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. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. The device is intended for single use only. Return all damaged devices and packaging to the manufacturer/distributor. 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. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Do not use open or damaged packages. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. This website is intended for US audience only. Penumbra's not relying on software alone. Precautions The device is intended for single use only. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Do not use open or damaged packages. [email protected] Saint Louis, Missouri Gus Theodos, MD, FACC, FSCAI The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Disclosures: None. If the cause cannot be determined, withdraw the device or system as a unit. Penumbra's high-performance aspiration catheters. The removal of fibrous, adherent or calcified material (e.g. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. gtag('js', new Date()); 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 . 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. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Physicians in the USA have published details ofto their knowledgethe "first reported use" of the Indigo aspiration system (Penumbra) to treat cerebral venous sinus thrombosis (CVST) via endovascular thrombectomy.The treated patient underwent successful partial recanalisation of the superior sagittal sinus (SSS) and bilateral transverse sinuses (TS), and experienced . INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . 3. Warnings/Precautions The canister is intended for single use only. Initial angiogram of the right pulmonary artery showing pulmonary embolism. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. 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. No modification of this equipment is allowed. Indication For Use Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Circulation. Indigo System Intended Use The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. System Chair, Clinical Research Figure 3. The CAT family of catheters is the foundation of Penumbra's Indigo System. Indication For Use Do not use kinked or damaged devices. Do not use kinked or damaged devices. Missouri Baptist Medical Center Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. function gtag(){dataLayer.push(arguments);} 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. J Am Coll Cardiol. function gtag(){dataLayer.push(arguments);} LIGHTNING Aspiration Tubing Indication for Use IN-DATE. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. The INDIGO SEPARATOR is not intended for use as a guidewire. 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 Indigo SystemCAT3, 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. Figure 2. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The complaint has been evaluated. Enter your email address and we will contact you. Possible complications include, but are not limited to, the following: Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Return all damaged devices and packaging to the manufacturer/ distributor. The newly available Indigo CAT12 Aspiration Catheter (Penumbra, Inc.) was utilized to perform mechanical thrombectomy of the FV, CFV, and EIV and CIV without the use of thrombolytics . Not for use in the coronaries or the neurovasculature. Final angiogram with complete TIMI 3 flow after the use of CAT RX. 0, 24. INDIGO Aspiration System Intended Use There are no contraindications. The device is intended for single use only. 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. Warnings/Precautions 0 cm from the hub. 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. Distal OD. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. [email protected] Worcester, Massachusetts Interventional Cardiology 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. Do not resterilize or reuse. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Ballad CVA Heart & Vascular Institute Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Use prior to the Use By date. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. 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 cerebral vasculature CAT7 and CAT12 are the next generation of the Indigo System Catheters. 22. 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). Jolly SS, Cairns JA, Lavi S, et al. St. Joseph Hospital The product-specific content of this website is intended for use by healthcare professionals only. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Do not use kinked or damaged devices. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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 median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. Use prior to the Use By date. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. 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. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Warnings 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. 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. The CAT family of catheters is the foundation of Penumbra's Indigo system. 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 . 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. Director, Structural Heart 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.). 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. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. S. Jay Mathews, MD, MS, FACC 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 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. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 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. 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. 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). Conclusions: evaluation of the cat8 revealed that the device was fractured. 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.

Joseline Hernandez Mother, Neat Edges Knitting Garter Stitch, Mary Frederik Denmark Blog, Ursuline Basketball Roster, Articles C