Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the companys proprietary continuous, mechanical vacuum aspiration pump. (EXTRACT-PE). Otherwise, this could result in degradation of the performance of this equipment. Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The CAT familyof catheters is the foundation of Penumbras Indigo System. Do not resterilize or reuse. right-arrow For bilateral occlusions where thrombus is laced throughout the SFA in both legs and with potential for acute-to-chronic occlusion distally, the Indigo System provides a frontline treatment option that potentially preserves limb viability. Figure 4. Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. Figure 1. Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The clot detection algorithm paired with the audiovisual cues lets the physician know when the catheter is in thrombus versus when it is in blood. Venogram showing stents in the left CIV and EIV. Otherwise, this could result in degradation of the performance of this equipment. Charlotte, North Carolina
Precautions The device is intended for single use only. COVID has increased the awareness of the need for therapies that remove blood clots, and we are thrilled with the FDA clearance of the PE treatment indication for Lightning 12.. betsy@merrymancommunications.com Miami Cancer Institute
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. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE . The patients right leg was completely cold, insensate, and immobile from the thigh down. Precautions The device is intended or single use only. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Program Director, Vascular Fellowship & Integrated Residency
Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. COURSE OF TREATMENT. 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. The INDIGO SEPARATOR is not intended for use as a guidewire. 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. Lightning 12 combines the new Indigo System CAT12 aspiration catheter with Lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system's clot detection mechanism. Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO. Lightning 7 a and Lightning 12 a are made of laser-cut hypotube technology, designed to increase trackability and torqueability. Use prior to the Use By date. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Internet Explorer presents a security risk. 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. Determining and Applying Appropriate Use of Venous Care, With Kathleen Ozsvath, MD, and Elna Masuda, MD, left-arrow Lightning 12 combines the 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. Sustained aspiration from the Indigo System provides physicians with an alternative option for patients who are not ideal candidates for lytics or open embolectomy and provides a frontline therapy option that still preserves the use of any adjunctive therapy. As PE treatment options continue to grow, the EXTRACT-PE results with the Indigo System serve as a promising data set in helping move the PE landscape forward. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Figure 2. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. 310-560-8176. Good Samaritan Hospital
INDIGO Aspiration System Indication for Use The patient had a history of lower left extremity venous thrombus dating back to 2013, with chronic residual nonocclusive popliteal vein thrombus in 2018. Intraoperative angiography can identify any arterial imperfection after surgical thromboembolectomy, which may be corrected simultaneously by endovascular techniques. INDIGO Aspiration Catheters and Separators: 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. In the current treatment of PE, standard treatments such as anticoagulation, thrombolysis, and open embolectomy have limitations. Embolization: Expanding Evidence and Awareness. Figure 2. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Carrera LA, Reddy R, Pamoukian VN, et al. 5. Executive Vice Chairman
Stainless steel hypotube; Large lumen size and circumferential sweep enables maximized thrombus engagement; The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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. Large-bore embolectomy, when paired with a syringe, has led to variable results, with questions regarding the ideal technique to achieve a uniform state of vacuum aspiration.1 The catheters used to aspirate should ideally be atraumatic and easily deliverable to be able to access and establish flow through the lobar branches of the pulmonary artery (PA), reducing right heart strain and PA pressure. For more information, visit https://www.penumbrainc.com/indigo-lightning/. Associate Clinical Professor, University of South Florida College of Medicine
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. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. In this case, the PE patient had an extremely high PA pressure of 35 mm Hg, which we were able to significantly reduce by 40%. Penumbra continues to strive to bring innovative therapies to the medical community, and this is another important milestone that will help advance pulmonary embolism intervention, said Adam Elsesser, president and chief executive officer, Penumbra. Real-world use of the Indigo System Lightning 7 and Lightning 12 Intelligent Aspiration in arterial, pulmonary embolism, and venous cases. 2013;26: E5-7. Use prior to the Use By date. 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. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. 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. 1Virani, S.S. et al. An intuitive clicking sound is made by the device that signals that one is in free-flowing blood. Created with Sketch. The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Venogram showing CAT12 in the CIV. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. CAT12 features a large 0.131-inch lumen and angled tip for additional circumferential sweep (Figure 2). This website is intended for US audience only. The major adverse event rate in EXTRACT-PE was 1.7%, and patients had a median intensive care unit stay of < 1 day. ALAMEDA, Calif.--(BUSINESS WIRE)--Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo Aspiration System, Lightning 12. Use prior to the Use By date. Las Vegas, Nevada
When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. Eric Moldestad, MD
Industry Prospects Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of the device. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Betsy Merryman 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. Return all damaged devices and packaging to the manufacturer/ distributor. Mean PA pressure postintervention was 21 mm Hg. 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; and D. Chris Metzger, MD. According to Penumbra, Lightning 12 combines the company's new Indigo System Cat 12 aspiration catheter with its Lightning Intelligent Aspiration to enable physicians to focus on optimizing thrombus removal using the systems clot detection mechanism. Contraindications There are no known contraindications. Icahn School of Medicine at Mount Sinai
Lightning enables clot detection so the physician knows when the catheter is in thrombus and when it is in patent flow. Diagn Interv Radiol. Do not reuse. Interventional Radiology
When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Equipment is not safe for MR use. Thrombotic disease puts patients at high risk of . Do not resterilize or reuse. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. Image showing the total thrombus removed. Henderson Hospital
1. Dr. Arko is chief, Division of Vascular and Endovascular Surgery, Sanger Heart and Vascular Institute in Charlotte, North Carolina. Potential adverse . Percutaneous manual thromboaspiration was the first technique proposed, followed by a series of percutaneous mechanical thrombectomy devices based on a different mechanism of action (mechanical fragmentation, aspiration, rheolytic thrombectomy, and their combinations). Penumbra's Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. Professor, Cardiovascular Surgery
. The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. 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.
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