Administration Circulatory System Devices Panel Research Articles

Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel Meeting on Device-Based Therapies for hypertension.

Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel Meeting on Device-Based Therapies for hypertension.

Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel meeting on the INCRAFT AAA Stent Graft System.

On June 12, 2018, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to advise on the safety and effectiveness of the INCRAFT® AAA Stent Graft System for the treatment of abdominal aortic aneurysms (AAA) and to consider a premarket approval application sponsored by Cordis, Inc., for Unique identifier: NCT01664078 based on the results of the pivotal INSPIRATION trial (URL: https://clinicaltrials.gov/ct2/show/NCT01664078). The INCRAFT® AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. The stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, with the goal of isolating the aneurysmal sac and preventing sac rupture. The multicenter, prospective, non-randomized investigation trial met its primary composite safety and effectiveness endpoints but also showed higher-than-anticipated rates of stent fracture and endoleaks. The committee discussion focused on how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile, of the device. While the panel acknowledged the risk of the device, the panel's final vote supported that the benefits of the INCRAFT AAA Stent Graft System outweigh the risks and that a post-marketing study should be mandated. The FDA approved the device for use in complex access anatomies in December 2018.

Overview of the 2017 US Food and Drug Administration Circulatory System Devices Panel meeting on the Sentinel Cerebral Protection System

Overview of the 2017 US Food and Drug Administration Circulatory System Devices Panel meeting on the Sentinel Cerebral Protection System

Overview of the 2016 US Food and Drug Administration Circulatory System Devices Panel Meeting on the AngelMed Guardian System.

On March 16, 2016, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to consider a premarket approval application for the AngelMed Guardian System based on the results of the pivotal ALERTS trial (AngelMed for Early Recognition and Treatment of STEMI) (URL: http://www.clinicaltrials.gov. Unique identifier: NCT00781118). The system comprises an implantable device similar to a single-chamber pacemaker, an external device that the patient carries, and a physician console. The device analyzes ST-segment shift through a single active-fixation lead in the right ventricular apex. If ST shift is identified, then the implantable device vibrates and the external device flashes and sounds an auditory alarm. More than 1 in 3 acute myocardial infarctions occur without chest pain, most commonly in women, diabetic patients, and the elderly. ST shift occurs rapidly in humans following coronary balloon occlusion.1 The AngelMed Guardian aims to reduce time to presentation by alerting the patient to ST shift even in the absence of symptoms. The ALERTS trial tested the safety and effectiveness of the Guardian System. A Bayesian adaptive design was used to adjust sample size based on interim treatment effect. The trial enrolled high-risk patients with a history of coronary artery disease (97% had previous revascularization). The trial was stopped early because of concerns that the predictive model did not accurately account for new Q waves. Nine hundred ten patients had the Guardian implanted (451 in the treatment arm versus 456 in the control arm with the device deactivated). Study …

Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon.

The Lutonix® drug coated balloon (DCB) is a combination device composed of a standard percutaneous angioplasty balloon coated with paclitaxel. Depending on the balloon size, a dose density of 2μg/mm(2) yields a variable total dose raging from 1.5mg to 3.8mg. This drug coated balloon aims to provide improved patency rates in patients with symptomatic femoropopliteal de novo or restenotic atherosclerotic disease. On June 12, 2014, the Food and Drug Administration's (FDA) Circulatory System Devices Panel reviewed the Lutonix DCB premarket approval application (PMA). This PMA application was primarily based on data from the pivotal randomized, controlled and multicenter clinical trial, which compared the Lutonix DCB with PTA. This summary aims to describe the discussions and recommendations made by the advisory panel during the meeting. Based on the Panel's recommendations, it is possible that the FDA will approve this device.

Overview of the 2013 Food and Drug Administration Circulatory System Devices Panel Meeting on the MitraClip Delivery System

The MitraClip system (MCS; Abbott Vascular, Santa Clara, CA) is a percutaneously delivered device aimed at reducing severe mitral valve regurgitation (MR) by approximating the mitral valve leaflets. The device is introduced through the femoral vein and advanced into the left atrium through a transseptal puncture. With echocardiographic guidance, the MitraClip is permanently placed in a fashion that approximates the anterior and posterior leaflets as seen in the surgical technique by Alfieri and De Bonis,1 although it should be noted that this technique includes mitral annuloplasty as an essential component. After being in development for more than a decade, the MCS was approved for commercial use in Europe in 20082 and is recommended by the European Society of Cardiology for use in patients with symptomatic severe MR who are determined to be inoperable or at high surgical risk by a heart team and who have a life expectancy >1 year (recommendation Class IIb , Level of Evidence C ).3 The MitraClip is currently approved for use in >40 countries with >8000 patients having been treated with this device, most of whom are at high surgical risk.2 On March 20, 2013, the Food and Drug Administration’s (FDA’s) Circulatory System Devices Panel met to discuss the premarket approval (PMA) application for the MCS. The scientific data presented to support the PMA were based on the pivotal randomized, controlled Endovascular Valve Edge-to-Edge Repair Study (EVEREST) II trial,4 along with data from 2 registries: 1 derived from a subgroup analysis of the EVEREST II data and 1 derived from continued-access registries. The first US MCS clinical trial, EVEREST I, was a single-arm feasibility registry of 55 patients. This trial completed its 5-year follow-up with reassuring results. The pivotal EVEREST II trial, initiated in August 2005, was a randomized, controlled …

Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients

The Edwards SAPIEN transcatheter heart valve (THV) is approved for aortic stenosis patients considered inoperable because of high surgical risk. Based on the high-risk arm of the PARTNER trial, the Food and Drug Administration's Circulatory System Devices Panel reviewed an additional indication for use in high-risk, operable patients. Although several concerns were raised regarding safety, trial misconduct, and several subgroup analyses, most panel members agreed that the Edwards SAPIEN THV (Edwards Lifesciences LLC, Irvine, CA), when used in high-risk patients, is noninferior to surgical aortic valve replacement. The panel voted 11 to 0 (with 1 abstention) that the benefits of the Edwards SAPIEN THV do outweigh the risks for use in the indicated patient population. This summary aims to describe the discussions and recommendations made during the meeting. Based on the panel recommendation, the device was approved by the Food and Drug Administration.

Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System

The CardioMEMS Champion Heart Failure Monitoring System (CardioMEMS, Atlanta, Georgia) is a permanently implantable pressure measurement system designed to wirelessly measure and monitor pulmonary artery (PA) pressure and heart rate in heart failure (HF) patients to guide ambulatory HF management and to reduce HF hospital stays. On December 8, 2011, the Food and Drug Administration (FDA) Circulatory System Device Panel reviewed the CardioMEMS Champion HF Monitoring System premarket approval (PMA) application. The majority of Panel members agreed that that the discussed monitoring system is safe for use in the indicated patient population. However, new information reported by the FDA with regard to preferential support in management of patients in the treatment group raised concerns among the Panel members with regard to potential bias in analyzing the efficacy of the device itself. Additionally, Panel members raised concerns with regard to the efficacy of the device in certain patient subpopulations. Hence, most Panel members decided that there was not reasonable assurance that the discussed monitoring system is effective. This summary aims to describe the discussions and recommendations made during this meeting.

Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel Meeting on the ACCULINK and ACCUNET Carotid Artery Stent System

The Circulatory System Devices Panel of the Medical Devices Advisory Committee to the US Food and Drug Administration (FDA) was convened on January 26, 2011, to review the application by Abbott Vascular (Santa Clara, CA) for a post–market approval supplement (PMA-s) to extend the indications for use of their ACCULINK Carotid Stent System. The stent system had received FDA approval in 2004 for patients at high risk for adverse events after carotid endarterectomy (CEA). Abbott Vascular was seeking to extend its approval to patients at standard risk for CEA on the basis of the data and outcomes derived from the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST; ClinicalTrials.gov Identifier NC4732). Herein are presented the essential elements of that day-long meeting. ### Study Conception and Timeline The organizational work on the CREST project was initiated in 1996 by the project's executive committee, which first published on its concept, rationale, and design in 1997.1 The experiential basis for the trial was chiefly 2 small stenting registries in high-surgical-risk, symptomatic patients totaling ≈200 procedures and reporting mortality rates of up to 3% and stroke rates of between 3% and 6%.2,3 The CREST executive committee recognized the novel nature and early stage of the technique, and in accordance with the tenets of clinical equipoise, as well as to provide reassurance to randomizing physicians that a reasonable safety of carotid artery stenting (CAS) had been established at an operator level and across sites, a rigorous credentialing phase was detailed for all participating centers. One of the stated secondary goals of CREST, to describe this experience in the lead-in phase of CREST, has been completed and published elsewhere.4 Although a 3-year enrollment period was originally anticipated for the main randomized trial, based on 50 sites recruiting 20 symptomatic patients per year, CREST ultimately required nearly 8 …

Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the Edwards SAPIEN™ Transcatheter Heart Valve

Transcatheter aortic valve replacement (TAVR) has been developed as a novel approach for the treatment of high-risk patients with aortic stenosis (AS). Although surgical aortic valve replacement is the standard of care for patients with symptomatic AS, it is associated with poor outcome when applied to patients with extreme operative risk. This subset of patients is usually deferred from surgery and has done poorly with medical therapy alone with or without balloon aortic valvuloplsty (BAV).1–4 The Edwards SAPIEN™ transcatheter heart valve (THV) technology aims to provide treatment for patients with severe, symptomatic AS who are deemed inoperable. On July 20, 2011, the Food and Drug Administration's (FDA) Circulatory System Devices Panel reviewed the first transcatheter aortic valve system, Edwards SAPIEN™ THV premarket approval application. Meeting materials can be accessed at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm240575.htm. The premarket approval application was based on data from the pivotal US randomized clinical trial, Placement of Aortic Transcatheter Valves (PARTNER),5,6 which comprised two independent cohorts of patients (high-risk and inoperable patients). For the purpose of the application, only patients in the inoperable cohort (Cohort B) who were randomized to standard therapy versus TAVR were submitted and subsequently presented to the FDA seeking device approval. Following is a summary of the discussions and recommendations made during the Circulatory System Devices Advisory Panel meeting, along with some important insights regarding the clinical use of the Edwards SAPIEN™ THV in a postapproval era. The proposed indication of use stated, “The Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX, sizes 23 mm and 26 mm, and RetroFlex 3 Delivery System are indicated for transfemoral delivery in patients with severe AS who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing comorbidities would not preclude the expected …

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on the Endeavor Zotarolimus-Eluting Coronary Stent

Initial trials comparing stenting with balloon angioplasty demonstrated improved angiographic and clinical outcomes with the former.1–3 The main clinical problem with bare metal stents (BMS) became the development of in-stent restenosis.4–6 Early data suggested that drug-eluting stents (DES) could mitigate, if not abolish, this problem.7–9 Since the approval of DES, these devices have become the predominant stents used in percutaneous coronary interventions, regardless of indication. As of September 2007, the Cypher sirolimus-eluting stent (SES) (Cordis Johnson & Johnson, Miami Lakes, Fla) had been deployed in >3 million patients worldwide,10 and the millionth Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Mass) was implanted as of January 2005.11 Over the past 2 years, numerous reports of very late stent thrombosis (ST) with first-generation DES have surfaced. This highly morbid complication and data suggesting that death and myocardial infarction (MI) may be more common with DES12,13 have altered the focus of trials and registries working to determine optimal DES use. There is a hope that second-generation DES will be less prone to ST as a result of differences in drug, stent design, and polymer. Medtronic, Inc (Minneapolis, Minn) presented safety and efficacy data to a public meeting of the US Food and Drug Administration (FDA) Circulatory System Devices Panel (CSDP) in October 2007 on its Endeavor zotarolimus-eluting stent (ZES), seeking approval for the indication of treating de novo native coronary lesions ≤27 mm with reference vessel diameters of 2.5 to 3.5 mm. The FDA asked the CSDP to determine whether the data presented demonstrated a reasonable level of safety and effectiveness, with clinical benefits clearly outweighing short- and long-term risks of ZES use. Important efficacy end points included ischemia-driven target lesion revascularization (TLR) or target vessel revascularization (TVR); safety end points included death, MI, and ST. The …

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on Patent Foramen Ovale Closure Devices

Patent foramen ovales (PFOs) are common congenital cardiac defects that are more prevalent among patients experiencing cryptogenic stroke than among those with strokes of known origin. Medical treatment for these processes is often considered inadequate, and mechanical closure of the PFO is an attractive, albeit controversial, alternative. Although it is plausible that percutaneous PFO closure will reduce the rate of recurrent stroke in these patients, randomized trials examining the efficacy of devices in this setting have not been completed. In 2007, the Food and Drug Administration convened a meeting of the Circulatory System Devices Panel to discuss the necessity of randomized trials, as well as obstacles to trial enrollment and completion.

Overview of the 2006 Food and Drug Administration Circulatory System Devices Panel meeting on drug‐eluting stent thrombosis

Drug-eluting stents (DES) seemed likely to mitigate the problem of restenosis and have become the predominant stent deployed during percutaneous coronary intervention (PCI). Sustained concerns about the rate of stent thrombosis (ST), particularly very late ST (>1 year following PCI) led to a meeting of the Circulatory System Devices Advisory Panel to address "on-label" and "off-label" use as well as appropriate duration of dual antiplatelet therapy following DES. Over 40 presentations by members of the FDA, industry personnel, and leaders in the field of interventional cardiology helped set forth the body of data available on DES. Standardized definitions of ST created by the Academic Research Consortium were applied to existing randomized trials and registries. At the end of the 2-day session, the consensus of the panel was that "on-label" DES use is not associated with increased incidence of death and myocardial infarction (MI), although it is associated with increased rates of very late ST. "Off-label" use is associated with increased risk of death or MI when compared with "on-label" use. Insufficient data exist to determine the duration of clopidogrel that would minimize ST and bleeding risk, but the panel agreed with the current ACC/AHA/SCAI guidelines regarding dual antiplatelet therapy for at least 12 months in patients at low risk for bleeding, especially with "off-label" use. More data from trials designed with better control arms and prespecified analyses of complex patients and lesions subsets over longer periods of follow-up are needed.