cat8 penumbra catheter

Cedars Sinai Medical Center Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. This content is not intended to offer professional medical advice. 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. 2023 Bryn Mawr Communications II, LLC. These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX. The product-specific content of this website is intended for use by healthcare professionals only. Related Items. Otherwise, this could result in degradation of the performance of this equipment. Do not use kinked or damaged devices. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. Possible complications include, but are not limited to, the following: 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. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Brandenton, Florida 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. Mathews SJ, Brown C, Kolski B, et al. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. right-arrow Disclosures: None. 5, 19. INDIGO System LIGHTNING Aspiration Tubing Intended Use 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. indicated to connect the INDIGO CAT RX Aspiration Catheters to 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. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Waqas R. Qureshi, MD, MS Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 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. The Indigo Aspiration System is contraindicated in: 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. 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. Jolly SS, Cairns JA, Yusuf S, et al. The device is intended for single use only. Equipment is not safe for MR use. 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. Throughout each case, Lightning provides procedural feedback via audio visual cues. Figure 1. The low-profile catheter and Penumbra ENGINE are easy to set up and use. Do not use kinked or damaged devices. The device is intended for single use only. 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). Do not use kinked or damaged devices. Learn more about Lightning. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). It will reduce service life of the Penumbra ENGINE. INDIGO Aspiration System Intended Use This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Disclosures: None. Lightning comes packaged with the Indigo CAT7 or CAT12. 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 advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. 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. After one pass with CAT RX, the initial occlusion was removed. Next Article CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. 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. UMassMemorial University Campus 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. 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. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. 0, 26. 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. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. The CAT family of catheters is the foundation of Penumbra's Indigo System. 8: Add BMK6F95M-NE . Maintain a constant infusion of appropriate flush solution. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). BJC Cardiology If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Director of Cardiac Catheterization Lab, PERT & Structural Heart The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Otherwise, this could result in degradation of the performance of this equipment. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Return all damaged devices and packaging to the manufacturer/distributor. Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). Flow through left circumflex artery post-CAT RX. Return all damaged devices and packaging to the manufacturer/distributor. Mechanical Thrombectomy. 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. 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. Return all damaged devices and packaging to the manufacturer/distributor. No modification of this equipment is allowed. Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications.