Penumbra Inc Research Articles

Mechanical Aspiration of a Heavy Thrombus in the Left Anterior Descending Artery using Penumbra Aspiration Catheter

Left anterior descending artery thrombosis is a medical emergency that requires prompt intervention to achieve the best possible clinical outcomes [1]. Early recanalization of obstructed vessels and thrombectomy with subsequent stenting effectively restore blood flow and improve procedural outcomes [2]. However, Manual Aspiration Thrombectomy (MAT) using a flexible aspiration catheter is also an alternative method that can be used to open blocked vessels [3]. Recent advancements in aspiration catheters have improved their trackability and size, making them comparable in efficacy to SBT [4]. As a result, Stent-Based Thrombectomy (SBT) and mechanical aspiration thrombectomy have become the primary treatment options for endovascular therapy in particular cases of coronary artery disease. The concurrent utilization of SBT and MAT as first-line and fallback interventions has been demonstrated to be effective in restoring vascular recanalization [5]. Besides SBT and MAT, a new aspiration catheter device has emerged. It is a relatively new technique for treating a thrombus in LAD that involves using a specialized catheter to remove the blood clot from the culprit artery [6]. This minimally invasive procedure is faster and more effective than traditional treatments such as thrombolytic therapy or Percutaneous Coronary Intervention (PCI) [7]. Penumbra medical technology company (Penumbra Inc, Alameda, CA, USA) introduced the Aspiration System in 2014 [8]. This system is specifically designed to remove blood clots from veins and arteries in the "peripheral vasculature" as well as for the treatment of "pulmonary embolism" [9]. The CAT family of catheters, developed by Penumbra, is known for its robustness, trackability, and atraumatic design, making it well-suited for peripheral anatomy where a thrombus forms [10]. The system comes equipped with the "Penumbra ENGINE aspiration source," which can administer almost untainted and consistent vacuum to catheters. This proficiency enables the extraction of thrombus in vessels of assorted dimensions. Recently, a penumbra aspiration catheter was used in a case report to remove thrombosis in acute coronary syndrome. According to the findings presented in this case report, it can be deduced that the Penumbra CAT RX catheter represents a secure and remarkably efficient alternative for eliminating blood clots in urgent scenarios. Notably, this method mitigates the heightened vulnerability to stroke often associated with the conventional approach of manual aspiration thrombectomy [11]. Previously, penumbra reperfusion catheter and MAT have been used as a "first-line therapy," and SBT with a "Solitaire stent" as a rescue therapy since 2012. This approach showed promising results regarding vessel recanalization and clinical outcomes [12].

Experimental evaluation of the performance of large bore aspiration catheters

Background and purposeMechanical thrombectomy using an aspiration catheter (AC) is widely performed in patients with acute ischemic stroke due to large vessel occlusion. AC diameter directly impacts aspiration performance, which has led device companies to develop large bore ACs. The purpose of this study was to evaluate the in vitro performance of several commercially available large bore ACs. Materials and methodsWe conceived an experimental set up to assess tracking force, aspiration flow rate, and distal end tensile force pre- and post-thrombectomy of ACs including Sofia 6 (Microvention Inc., California, USA), React 71 (Medtronic Neurovascular, Irvine, California, USA), Jet 7 (Penumbra Inc, Alameda, California, USA), Catalyst 7 (Stryker Neurovascular, Kalamazoo, Michigan, USA) and Embovac 071 (Johnson & Johnson Medical Ltd, UK). ResultsReact 71 and Sofia 6 had significantly lower trackability force compared to the other ACs tested. Distal AC segment tensile force was highest for React 71 and lowest for Jet 7. Jet 7 had the highest internal diameter and the highest aspiration flow rate. ConclusionThe data from this comparative analysis may assist clinicians in selecting the appropriate AC and highlights the need for key performance criteria during the development of next-generation large-bore ACs for optimal AC performance.

Trancatheter embolization of pulmonary artery pseudoaneurysm with detachable coils in association with non-adhesive liquid embolizing agent (Squid).

A nodular lesion at the lower left pulmonary lobe was detected in a 46 years old male during a preoperative chest X-Ray for appendicitis. To further characterise the nodule, a contrast enhanced computed tomography (CE-CT) was performed showing a 20 mm vascular lesion, which was suspected to be a pseudoaneurysm. The diagnostic angiography detected a flattening of the vascular wall with a voluminous pseudoaneurysm (PSA) in the distal portion of the tributary branch of the inferior left lobe. To treat the lesion, a 2.9F microcatheter was advanced into the sac and 4 detachable coils were placed (16-18mm Penumbra Inc) to pack the PSA. To block vascular supply to the lesion, the feeding artery was embolized with an ethylene vinyl alcohol copolymer agent (Squid Peri 18, Emboflu). The final angiographic control showed the exclusion of the pseudoaneurysmal sac which was confirmed by SEMAR™ reconstructed CE-CT scan after 40 days. Furthermore, no signs of pulmonary infarction were reported. (www.actabiomedica.it).

Treatment of Symptomatic Paravisceral Aortic Thrombus Using Percutaneous Suction Thrombectomy

Paravisceral aortic thrombus in an otherwise normal aorta is rare. A hemodynamically significant thrombus burden in such patients can result in visceral malperfusion and bilateral lower extremity ischemia, both of which, historically, have a high mortality rate. Open thrombectomy via a thoracoabdominal approach is associated with high mortality. Other endovascular alternatives, including Fogerty embolectomy and mechanical thrombectomy, are associated with visceral embolization. The Penumbra CAT-12 lightning device (Penumbra Inc, Alameda, Calif) most commonly used to treat ileofemoral deep vein thrombosis is a 12F suction catheter with the ability to remove large amounts of clot burden with minimal blood loss owing to its sensor mechanism. The ability to suction thrombectomy-focused areas in the aorta reduces the likelihood of embolization. We have presented the cases of two patients with acute symptomatic paravisceral aortic thrombus who were treated with this device and their outcomes. Two patients had presented to the emergency room with acute onset abdominal pain and bilateral lower extremity rest pain and numbness. Patient 1 was a 46-year-old woman with antithrombin III and protein C deficiency (Fig 1). Patient 2 was a 78-year-old woman with recent coronavirus disease 2019 infection, chronic obstructive pulmonary disease, and congestive heart failure (Fig 2). Computed tomography angiography of patients demonstrated aortic thrombus in the paravisceral aorta extending from the supraceliac to the infrarenal aorta. Both patients underwent percutaneous suction thrombectomy of the aorta using the Penumbra CAT-12 lightning device. Patient 2 also underwent bilateral femoral cutdown, thrombectomy, and kissing iliac stents, followed by diagnostic laparoscopy without any further intervention. The intraoperative angiographic images demonstrated the initial aortic thrombus in the paravisceral aorta with resolution of thrombus after suction thrombectomy (Figs 1 and 2). The abdominal pain and bilateral lower extremity rest pain had resolved in both patients postoperatively and did not require any further surgical intervention. Patient 1 was discharged home on postoperative day 3. Patient 2 was discharged to a rehabilitation facility on postoperative day 10. Percutaneous suction thrombectomy devices such as the Penumbra CAT-12 lightning device is effective in removing a large paravisceral aortic clot burden without any embolization to the visceral vessels. This is a newly available alternative to consider for such patients with symptomatic paravisceral aortic thrombus considered to have a high mortality risk with open intervention.Fig 2a, Angiogram demonstrating aortic thrombus at the level of the superior mesenteric artery. b, Coronal view of paravisceral aortic thrombus. c, Abdominal aortogram demonstrating improvement in paravisceral thrombus burden with embolization of thrombus to the aortic bifurcation. d, Lateral aortogram demonstrating patent and disease-free celiac and superior mesenteric artery. e, Aortogram after bilateral femoral embolectomy and bilateral kissing iliac stents showing flow to the lower extremity and pelvis restored with no further thrombus burden. f, Post-op CTA demonstrating aortic lumen patency at the SMA take-off.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Use of a clot aspiration system during transvenous lead extraction.

The optimal approach to the extraction of leads with large vegetations remains uncertain. High-risk patients with lead associated vegetations undergoing device extraction at Vanderbilt Hospital with concomitant use of the Penumbra Aspiration System (Penumbra Inc, Alameda, CA) are described. An 8.5 Fr Agilis NXT (Abbott Inc, St. Paul, MN) was advanced to the right atrium, through which a Penumbra Indigo Cat-8 catheter was advanced. Using intracardiac echocardiography, the Penumbra was positioned directly on the vegetation, suction was applied until adherent, and the Indigo catheter and Agilis sheath were then removed en-bloc and aspirated debris flushed out. This was repeated until debulking was considered successful. Eight cases were performed. The median vegetation size was 2 cm. Pathogens were Enterococcus, Staphylococcus, Candida, Cutibacterium, and Enterobacter. In seven of eight cases, aspiration successfully reduced vegetations to less than 1 cm before successful percutaneous cardiac implantable electronic device removal. One patient underwent surgical removal via thoracotomy. There were no acute complications related to the Penumbra catheter. Three patients had CT evidence of small pulmonary emboli postprocedure. The length of stay was 3 to 27 days. One patient died on POD 1 of refractory ventricular tachycardia unrelated to the procedure. One patient died of ongoing sepsis 2 weeks postextraction. The Penumbra Indigo Aspiration system can be useful for vegetation debulking before transvenous lead extraction.

Single-center experience with Indigo aspiration thrombectomy for acute lower limb ischemia

Acute lower limb ischemia (ALLI) is a challenging vascular emergency with notable morbidity. Aspiration mechanical thrombectomy (AMT) devices are an alternative approach to remove thrombus in the peripheral arterial system and to restore limb perfusion, but data are limited. We evaluated the outcomes of AMT for the treatment of ALLI at our institution. We performed a single-center retrospective review of patients with ALLI treated with Indigo (Penumbra Inc, Alameda, Calif) AMT device from 2014 to 2017. The primary outcome was technical success (restoration of blood flow with<50% residual thrombus without need for catheter-directed thrombolysis [CDT] or open surgery) as main treatment or adjunctive treatment (after failure of another modality). Indications, anatomic segments treated, outcomes, and complications were reviewed. There were 41 patients (68% male, 32% female; mean age, 67years; range, 27-90years) who underwent 43 procedures. The cause of ALLI was embolism (18), native vessel thrombosis (13), bypass thrombosis (7), intraluminal thrombus due to pseudoaneurysm (1), stent thrombosis (1), intraprocedural embolization (1), recurrent thrombosis of native vessel (1), and chronic thrombosis (1). AMT was the main treatment in 29 cases and adjunctive in 14. Technical success was 52% (15/29) as main treatment and 50% (7/14) as adjunctive treatment. Thrombolysis was avoided in 53% of patients (23/43). There were six thrombotic recurrences, one after successful isolated AMT. The other five required multiple modalities after AMT failure. There were no 30-day deaths. Five patients required amputations, but only one after successful AMT. Complications included intraoperative distal embolization (two), access site hematoma (one), pseudoaneurysm (one), acute kidney injury (one), and spontaneous calf hematoma (one). There were no blood transfusions required or severe bleeding complications. With an overall success rate of 51% in selected patients, the Indigo AMT device avoided the need for CDT or open surgery in about half of patients with ALLI. The device has a favorable safety profile, particularly in high-risk cases. Given its moderate effectiveness, the role of Indigo AMT in the management of ALLI will further be defined by the description of optimal technique, the determination of treatment indications, and a direct comparison with CDT.

Overview of Mechanical Thrombectomy Techniques.

The recently reported superiority of mechanical thrombectomy to intravenous thrombolytics has jettisoned endovascular intervention into the forefront of acute ischemic stroke (AIS) management. These successes have allowed a chance for recanalization for patients not meeting the strict eligibility criteria for intravenous thrombolytics. Stent retrieval and aspiration have emerged as two of the most popular and effective approaches for AIS thrombectomy. Since the beginning of mechanical thrombectomy with the Merci device (Stryker) and first-generation Penumbra aspiration system (Penumbra Inc), contemporary techniques have demonstrated reliable recanalization and improved clinical outcomes. Here, we review the use of stent retrieval and aspiration, as well as their synergy, in the management of AIS.

The Indigo System in Acute Lower-Limb Malperfusion (INDIAN) Registry: Protocol.

BackgroundAcute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis.ObjectiveThe devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.MethodsThis study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month.ResultsThe study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will be recruited. Analyses will focus on primary and secondary endpoints.ConclusionsThese new endovascular thrombectomy devices that are specifically designed for peripheral intervention in this difficult set of patients, as those under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. Following completion of this study, it is expected that the value of the Indigo Thrombectomy System in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendations toward endovascular options may be observed in the near future.International Registered Report Identifier (IRRID)DERR1-10.2196/9972

Image-guided, Minimally Invasive Evacuation of Intracerebral Hematoma: A Matched Cohort Study Comparing the Endoscopic and Tubular Exoscopic Systems.

IntroductionNovel image-guided, minimally invasive techniques to evacuate intracerebral hematomas represent a promising new avenue in the management of this disease entity. To our knowledge, a direct comparison of the Penumbra Apollo (Penumbra Inc, Alameda, California, US) and Nico BrainPath (Indianapolis, Indiana, US) system has not yet been performed.MethodsA retrospective review of image-guided, minimally invasive evacuation of intracerebral hematomas performed at one academic institution in the United States between July 2015 and July 2017 was performed. Cases performed with the Apollo and BrainPath system were matched based on age, gender, hematoma location and laterality, and volume.ResultsTwenty-four patients underwent surgery using either of the two minimally invasive surgical systems and five cases in each group were matched for age, gender, hematoma location and laterality, and volume. Median time from symptom onset to evacuation was two days with a mean distance from the brain surface to the clot of approximately 40 millimeters in both groups. Both techniques achieved comparable clot evacuation. The functional outcome was poor with either technique with the majority of patients dependent or dead at last follow-up.ConclusionsIn the present, small, matched cohort study, both the Apollo and BrainPath techniques achieved satisfactory clot evacuation. Nevertheless, the functional outcome in this patient population remains poor in the majority of cases.

305 The INVEST Trial

Abstract Spontaneous intracerebral hemorrhage (ICH) is a common subtype of hemorrhagic stroke, with the poorest prognosis of all stroke subtypes. Today's standard of care for these patients result in high mortality, lengthy recovery times, and low functional improvements. The goal of the INVEST trial is to evaluate the safety and efficacy of minimally invasive hemorrhage evacuation with the Apollo device (Penumbra Inc, Alameda, California) compared with medical management. The INVEST study is a prospective multicenter US trial designed to enroll 222 patients at up to 30 centers. Patients between the ages of 22 and 80 or

Advances in minimally invasive treatment of hemorrhagic and ischemic stroke.

Advances in minimally invasive treatment of hemorrhagic and ischemic stroke.

Lower vertebral-epidural spinal arteriovenous fistulas: a unique subtype of vertebrovertebral arteriovenous fistula, treatable with coil and Penumbra Occlusion Device embolization

A vertebral-epidural spinal arteriovenous fistula (AVF) is an abnormal arteriovenous shunt connecting the vertebral artery to the spinal epidural venous plexus, and may occur spontaneously or secondary to a variety...

Initial multicenter technical experience with the Apollo device for minimally invasive intracerebral hematoma evacuation.

No conventional surgical intervention has been shown to improve outcomes for patients with spontaneous intracerebral hemorrhage (ICH) compared with medical management. We report the initial multicenter experience with a novel technique for the minimally invasive evacuation of ICH using the Penumbra Apollo system (Penumbra Inc, Alameda, California). Institutional databases were queried to perform a retrospective analysis of all patients who underwent ICH evacuation with the Apollo system from May 2014 to September 2014 at 4 centers (Medical University of South Carolina, Stony Brook University, University of California at San Diego, and Semmes-Murphy Clinic). Cases were performed either in the neurointerventional suite, operating room, or in a hybrid operating room/angiography suite. Twenty-nine patients (15 female; mean age, 62 ± 12.6 years) underwent the minimally invasive evacuation of ICH. Six of these parenchymal hemorrhages had an additional intraventricular hemorrhage component. The mean volume of ICH was 45.4 ± 30.8 mL, which decreased to 21.8 ± 23.6 mL after evacuation (mean, 54.1 ± 39.1% reduction; P < .001). Two complications directly attributed to the evacuation attempt were encountered (6.9%). The mortality rate was 13.8% (n = 4). Minimally invasive evacuation of ICH and intraventricular hemorrhage can be achieved with the Apollo system. Future work will be required to determine which subset of patients are most likely to benefit from this promising technology.

Abstract W P13: Time To Recanalization With New Thrombectomy Devices In Intra-arterial Therapy For Acute Ischemic Stroke

Introduction: Faster time to recanalization is a strong predictor of good outcome after acute ischemic stroke (AIS) from large vessel occlusion (LVO). Intra-arterial therapy is an option for AIS from LVO, but studies have not shown benefit with this modality. This may be related to delayed recanalization time. We compared the speed of recanalization with newer devices Methods: Retrospective study of patients who underwent IAT for AIS from 1/10 -6/14 at our institution was conducted. Data regarding baseline demographics, treatment times and thrombectomy devices were recorded for all patients who achieved successful recanalization defined as TICI2b-3. Comparisons were drawn between the patients who underwent IAT with the Penumbra aspiration system (Penumbra Inc, Alameda, CA), stent-trievers and direct aspiration (DA) with new large bore catheters such as 5 MAX and 5 MAX ACE (Penumbra Inc). Results: 113 patients achieved successful recanalization. Penumbra aspiration was used in 48 (42.4%), stent-trievers in 37 (32.7%) and direct aspiration in 28 (24.7%) patients. Baseline demographics are detailed in the table and were non-significant between groups. Time from first run to recanalization was shortest in the DA group (49.5 ± 31.6 minutes), followed by Penumbra aspiration system (61.5 ± 39.8) and stent-trievers (71.6 ± 35.1). DA was significantly faster than Penumbra aspiration system (p 0.0354) and the stent-triever (0.0100). Conclusion: Improvements in device technology and interventional technique allows for effective recanalization in significantly shorter times compared to previous methods. The impact of these developments will have to be tested in randomized controlled trials to assess its influence on outcomes

O-029 The Importance of Core Infarct Volume in the Number Needed to Treat in Endovascular Therapy for Acute Ischemic Stroke

Introduction/purposeThe infarct core has been theorised to be an important indicator for treatment success from endovascular intervention in acute ischemic stroke from large vessel proximal occlusion. The objective of this...

O-006 Analysis of Screened Patients from the Penumbra THERAPY Trial: Correlations of Clot Length Assessed by Thin-Section CT in a Sequential Series of Acute Stroke Patients

PurposeThin-section (≤2.5 mm) NCCT is a dependable method for measurement of clot length in documented anterior circulation occlusions. A majority of clots in the proximal anterior circulation are ≥8 mm,...

O-002 Single Center Experience Comparing Outcomes of Strokes Treated with Mechanical Thrombectomy vs Without Mechanical Thrombectomy Using CTP for Patient Selection

PurposeMost patients with large vessel occlusion (LVO) present with high NIHSS, and it has been shown that initial NIHSS is a predictor of outcomes in patient with acute ischemic stroke....

O-017 Minimally Invasive Angiographic CT Guided Evacuation of Parenchymal and Ventricular Haemorrhage Using the Apollo System: Proof of Concept in a Cadaver Model

IntroductionApollo (Penumbra Inc, Alameda, CA) is a low profile irrigation-aspiration system designed for the evacuation of intracranial haemorrhage. We demonstrate the feasibility of using Apollo through a minimally invasive approach...

Minimally invasive cone beam CT-guided evacuation of parenchymal and ventricular hemorrhage using the Apollo system: proof of concept in a cadaver model

IntroductionThe Apollo system (Penumbra Inc, Alameda, California, USA) is a low profile irrigation–aspiration system designed for the evacuation of intracranial hemorrhage.ObjectiveTo demonstrate the feasibility of using Apollo in combination with...

E-052 Initial Institutional Experience with the Sceptre XC Balloon for the Endovascular Treatment of Cerebral Aneurysms

Background and purposeThe Sceptre XC balloon is a novel extra-compliant dual-lumen balloon microcatheter designed for the endovascular treatment of cerebral aneurysms and arteriovenous malformations. This study aims to describe our...