Good Samaritan Hospital Do not use open or damaged packages. 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. Dr. Arko continued, "When dealing with thrombus, we have learned that it is the combination of the catheter along with powered aspiration that yields the most effective results. Created with Sketch. Dr. Benenati will join Penumbra on September 1, 2020, and will contribute to clinical and medical affairs strategies and advise upon global commercialization and market development activities. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. 5. Gianmarco de Donato, MD Immediately after, Lightning with the Indigo System Catheter CAT8 was used to aspirate thrombus in the left PA (, Due to increased amounts of thrombus in the right lobe, the SEP8 was introduced to clear the lumen of the catheter (. Total aspiration time was 34 minutes. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Venogram showing thrombosis of the left FV and CFV. Kingsport, Tennessee A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Do not use kinked or damaged devices. 12 F Laser Cut Hypotube Catheter. Aspiration may also be performed in conjunction with an Indigo System Separator (Penumbra, Inc.) to allow for constant clearing of thrombus from the lumen of the catheter. The Indigo System has demonstrated high rates of revascularization with consistent success. Figure 3. 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. Figure 6. Circulation. The results may not be predictive of all patients. Do not resterilize or reuse. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on February 26, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC on May 7, 2020, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the SEC on August 3, 2020, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the SEC on November 2, 2020. It will reduce the service life of the PENUMBRA ENGINE. CT revealed an occlusion in the popliteal artery (Figure 1). If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Precautions The device is intended or single use only. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). Warnings/Precautions The canister is intended for single use only. Figure 1. Disclosures: Consultant to Penumbra, Inc. A 68-year-old man presented with a sudden coolness in both legs after stopping apixaban therapy for 3 days. Precautions The device is intended or single use only. PEN recently announced the commercial availability of its INDIGO System Lightning 7 in the United States. The Indigo System of catheters are trackable, deliverable, and can provide a nice treatment option for complex patients. 1Virani, S.S. et al. Angiography after Indigo power aspiration and popliteal aneurysm repair with a stent graft (Viabahn, Gore & Associates) revealed a patency of the tibial (A) and plantar (B) vessels. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Do not use open or damaged packages. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. July 14, 2020Penumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the companys next-generation aspiration system for peripheral thrombectomy. Plus, get our latest issues & supplements delivered to your inbox each month. Use only water-based solvents for cleaning. Next Article CT showed a bilateral PE with right heart strain. Do not use kinked or damaged devices. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Use prior to the Use By date. Potential adverse . Such results give more evidence for a shift of treatment recommendation toward endovascular options in the patients with ALI, as already suggested by the recent European Society of Cardiology/European Society for Vascular Surgery guidelines. Michael S. Rosenberg, MD, FSIR, FACR Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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 the PENUMBRA ENGINE. 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. With a device time of only 5 minutes and no use of tPA, the patients symptoms were promptly relieved with no recurring episodes to date. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . Figure 7. We gained access through the right CFV using a 14-F sheath. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. All Rights Reserved Privacy Policy, With Frank R. Arko III, MD; Patrick E. Muck, MD, RVT, FACS; Ripal T. Gandhi, MD, FSIR, FSVM; Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM; Michael S. Rosenberg, MD, FSIR, FACR; Eric Moldestad, MD; Gianmarco de Donato, MD; Thomas S. Maldonado, MD; D. Chris Metzger, MD, Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM. Professor, FIU Herbert Wertheim College It is a welcome addition to our existing endovascular technologies for the treatment of acute PE. The patient had a history of lower left extremity venous thrombus dating back to 2013, with chronic residual nonocclusive popliteal vein thrombus in 2018. At the 30-day follow-up, the patient no longer had residual shortness of breath or exertional dyspnea. However, these hybrid procedures include the invasiveness of open surgery and carry the risk of incomplete thrombus removal or vessel damage.1, Consequently, many new endovascular devices have been proposed to increase treatment success, decrease complications, and rapidly improve perfusion. University of Minnesota There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. 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. 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. Professor of Radiology and Surgery If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Pulmonary embolism, or PE, is a deadly condition causing blood clots within a patients lungs that has grown in prevalence during the COVID-19 pandemic. Penumbra, a global healthcare company, has secured the expanded US Food and Drug Administration 510 (k) approval for the new generation of its Indigo Aspiration System, Lightning 12. Evaluating the safety and efficacy of the Indigo aspiration system in acute pulmonary embolism. Penumbra augments vascular franchise with latest Indigo System launch A wire test was conducted in the right leg to determine the composition of the clot. Chief of Vascular Surgery Intraoperative angiography can identify any arterial imperfection after surgical thromboembolectomy, which may be corrected simultaneously by endovascular techniques. Endovascular Today (ISSN 1551-1944 print and ISSN 2689-792X online) is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field. STRIDE is currently ongoing. 2. The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Designed for single session arterial thrombus removal, New angled tip shape for maximized clot extraction, Dual pressure sensors for real-time flow monitoring, Large lumen size and circumferential sweep enables maximized thrombus engagement, Multi-pitch hypotube for 1:1 torque transfer and advanced deliverability, Indicated for the treatment of pulmonary embolism. J Vasc Interv Radiol. IVUS image showing a widely patent lumen after thrombectomy and stenting. Disclosures: None. Penumbra continues to lead the field of clot management by bringing highly innovative technology to address the challenges that we as physicians face while caring for our patients, commented Frank Arko, MD, in the company's announcement. Do not use in oxygen rich environment. Disclosures: Owns public stock in Penumbra; consultant and course director for Penumbra, Inc. A 77-year-old woman presented to the emergency department with a history of esophageal varices and bleeding, contraindicating her for tissue plasminogen activator (tPA). Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. Do not resterilize or reuse. Scans revealed a left lower extremity venous thrombus extending from the calf to the common iliac vein (CIV) (Figure 1). Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Use prior to the Use By date. FDA Clears Penumbra's Lightning 12 Aspiration Catheter for Pulmonary Previous Article, Reversing the Death Spiral: FlowTriever Thrombectomy for High-Risk PE, With James Horowitz, MD, FACC; Mitchell J. Determining and Applying Appropriate Use of Venous Care, With Kathleen Ozsvath, MD, and Elna Masuda, MD, left-arrow . Disclosures: None. Penumbra Launches Indigo System Lightning 12 and Appoints Medical and Restored distal flow to the left TPT. 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 the PENUMBRA ENGINE. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. 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. Earlier in November 2020, Penumbra announced the receipt of 510(k) FDA clearance for an expanded indication of the latest iteration of the Indigo Aspiration System, Lightning 12. Continuous, sustained aspiration can effectively remove thrombus and potentially reduce the use of thrombolytics. Schwartz-Buckley Professor of Surgery, Vascular Division The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Scan showing preoperative left venous thrombus. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Figure 3. Penumbra Augments Vascular Franchise with Latest Indigo System Launch of Medicine 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. Postprocedural CT of the patients left pulmonary anatomy. Figure 1. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . Lightning 12 combines the Indigo System CAT12 aspiration catheter with lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system's unique clot detection mechanism. New York University Langone Medical Center Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Created with Sketch. The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. Maintain a constant infusion of appropriate flush solution. Eur J Vasc Endovasc Surg. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. New York, New York The device is intended for single use only. In this next phase, Penumbra is set to broaden its reach on a global scale, and I am thrilled to join this excellent team and help accelerate the impact of its products.. This website is intended for US audience only. Figure 1. The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. Penumbra Announces the European Launch of the Indigo System With Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Indigo System - Vascupedia Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism . Penumbra Augments Vascular Franchise with Latest Indigo System Launch 2014;59:729-36. INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . 2. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Do not resterilize or reuse. The Next Generation of Thrombus Removal | Penumbra Inc From syringe aspiration to sustained aspiration and now to intelligent aspiration, the aspiration thrombectomy field has grown leaps and bounds, now finding itself at a place where the Indigo System with the Lightning Intelligent Aspiration optimizes the thrombus removal procedure by differentiating between thrombus and blood. CAT3 advanced through the pedal loop (C). A venogram was performed via left popliteal vein access, which demonstrated thrombosis of the left femoral vein (FV) and common femoral vein (CFV) (Figure 1) and the previously stented left common iliac vein (CIV) and external iliac vein (EIV) (Figure 2). Ripal T. Gandhi, MD, FSIR, FSVM Contraindications There are no contraindications. LIGHTNING Aspiration Tubing Indication for Use Disclosures: None. The decision was made to proceed with mechanical thrombectomy. Otherwise, this could result in degradation of the performance of this equipment. In PE cases, patients are often emergent and need interventions that provide immediate relief. Many of the first-generation mechanical endovascular devices for thrombus removal have failed to be adequately successful or have been associated with unacceptable complication rates. Do not re-infuse blood or fluid from the canister back into the patient.
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