2017;377:2240-2252. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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). Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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 low-profile catheter and Penumbra ENGINE are easy to set up and use. J Vasc Interv Radiol. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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. 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 Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. . Do not use kinked or damaged devices. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. INDIGO Aspiration System Intended Use gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The product-specific content of this website is intended for use by healthcare professionals only. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Learn more about Lightning. Suhail Dohad, MD, FACC
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; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; 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; hemoptysis; respiratory failure; thromboembolic events. Figure 3. Figure 3. System Chair, Clinical Research
These pages are not intended for patients or for members of the general public. Warnings 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 provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. 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. 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. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. 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. Do not use in oxygen rich environment. Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. 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). Maintain a constant infusion of appropriate flush solution. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Potential Adverse Events Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. gtag('js', new Date()); 5, 19. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Orange, California
Do not resterilize or reuse. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. Waqas R. Qureshi, MD, MS
0, 26. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The CAT family of catheters is the foundation of Penumbra's Indigo System. Do not re-infuse blood or fluid from the canister back into the patient. 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. 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. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Figure 2. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Return all damaged devices and packaging to the manufacturer/distributor. Penumbra Aspiration Pump: Figure 2. The results may vary depending on a variety of patient specific attributes. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Mechanical thrombectomy was performed. She was in a rehab facility prior to this new event recovering from her CVA. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. 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. This content is not intended to offer professional medical advice. Indication For Use 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. The Indigo Separator 4 is not intended for use as a guidewire. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . 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. Learn more about Lightning. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. 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. Do not reuse. Kingsport, Tennessee
The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. Do not use open or damaged packages. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. kolskiwellness@gmail.com
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. 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. Penumbra ENGINE Intended Use When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. function gtag(){dataLayer.push(arguments);} Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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). Final angiogram after mechanical thrombectomy with CAT8 and SEP8. The CAT family of catheters is the foundation of Penumbra's Indigo System. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Saxon RR, Benenati JF, Teigen C, et al. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Final angiogram with complete TIMI 3 flow after the use of CAT RX. 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 median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 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 The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. University of Massachusetts Medical School
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. 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. $399.00 EACH. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Enter your email address and we will contact you. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. J Am Coll Cardiol. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . 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. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. The device is intended for single use only. Figure 2. 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 . Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 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. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). 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. Disclosures: None. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. If the cause cannot be determined, withdraw the device or system as a unit. Penumbra's not relying on software alone. Sista A. Indigo aspiration system for acute pulmonary embolism. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 1. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Figure 1. 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. 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. Lightning comes packaged with the Indigo CAT7 or CAT12. 0, 24. Use prior to the Use By date. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Otherwise, this could result in degradation of the performance of this equipment. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Contraindications There are no known contraindications. Circulation. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Figure 1. The complaint has been evaluated. UMassMemorial University Campus
Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Contraindications CAT7 and CAT12 are the next generation of the Indigo System catheters. 2. Precautions The device is intended for single use only. 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. This press release features multimedia. Penumbra, Inc. One Penumbra Place. The removal of fibrous, adherent or calcified material (e.g. The Indigo System utilizes the Penumbra ENGINEaspiration 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. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Chris Metzger, MD
Ultrasound-guided access was obtained through the right femoral vein. 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. 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. These pages are not intended for patients or for members of the general public. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. SVG occlusions can be challenging to resolve using traditional treatment modalities. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Equipment is not safe for MR use. Ballad CVA Heart & Vascular Institute
TIMI 3 flow was achieved in 88% of cases. Initial angiogram showing high thrombus burden in the RCA. 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. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Warnings Additional Details. 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. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Return all damaged devices and packaging to the manufacturer/distributor. Potential Adverse Events The system uses Penumbra's RED reperfusion catheters. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. 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. 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 Aspiration Tubing: 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. Precautions The device is intended for single use only. Maintain a constant infusion of appropriate flush solution. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 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. 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. Do not resterilize or reuse. This content is not intended to offer professional medical advice. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). 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.