The ASCEND EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of the study is to evaluate the Investigational Devices through at least 3-months of follow-up to inform the design of a subsequent pivotal clinical investigation.
The objectives of the study are to: 1) preliminarily validate safety and effectiveness of the Atala™ lead as a permanent ICD lead when used with a compatible ICD pulse generator, 2) evaluate suitability of clinical study testing methods and 3) inform statistically powered primary safety and effectiveness endpoints in a subsequent pivotal clinical investigation.

开始日期2025-02-25

申办/合作机构

AtaCor Medical, Inc.初创企业

NCT05610033 / Active, not recruitingN/A

Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study

The PIONEER EV PACING Study is prospective, multi-center, acute (in-hospital), single-arm, pilot study. The study objective is to characterize preliminary safety and performance of the AtaCor EV Temporary Pacing Lead System when used as intended for clinical use as a temporary pacing lead.

开始日期2023-09-19

申办/合作机构

AtaCor Medical, Inc.初创企业

NCT05791032 / CompletedN/A

Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study

STEP ICD is a premarket, exploratory, early feasibility, interventional study designed to evaluate the preliminary safety and performance of the Investigational Devices. The study is intended to inform the final device design which will be further evaluated in traditional feasibility and /or pivotal clinical investigations.
The primary safety objective is to characterize safety of the EV-ICD Lead through 3 months post-implant. The primary performance objective is to characterize sensing and conversion of induced VF with the EV-ICD Lead up to 3 months post-implant.

开始日期2023-09-05

申办/合作机构

AtaCor Medical, Inc.初创企业

100 项与 AtaCor Medical, Inc. 相关的临床结果

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0 项与 AtaCor Medical, Inc. 相关的专利（医药）

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项与 AtaCor Medical, Inc. 相关的文献（医药）

2023-08-01·Circulation. Arrhythmia and electrophysiology

Initial Experience With Intercostal Insertion of an Extravascular ICD Lead Compatible With Existing Pulse Generators

Article

作者: Sanghera, Rick ; Marcovecchio, Alan ; Aasbo, Johan ; Burke, Martin C ; Pepplinkhuizen, Shari ; O'Connor, Mark ; Reddy, Vivek ; Knops, Reinoud E ; Ebner, Adrian ; Scheck, Don ; Husby, Michael

BACKGROUND::

This study assessed safety and feasibility of a novel extravascular implantable cardioverter defibrillator (ICD) lead when inserted anteriorly through a rib space and connected to various commercially available ICD pulse generators (PGs) placed in either a left mid-axillary or left pectoral pocket. Currently available or investigational, extravascular-ICDs include a subcutaneous or subxiphoid lead connected to customized extravascular-ICD PGs.

METHODS::

This novel extravascular-ICD (AtaCor Medical Inc, San Clemente, CA) employs a unique intercostal implant technique and is designed to function with commercial DF-4 ICD PGs. In this nonrandomized, single-center, acute study, 36 de novo or replacement ICD (transvenous ICD) patients enrolled to receive a concomitant extravascular-ICD lead inserted through an intercostal space along the left parasternal margin. extravascular-ICD leads were connected to DF-4 compatible ICD PGs positioned in either a left mid-axillary or pectoral pocket for acute sensing and defibrillation testing. Defibrillation testing started at 30 Joules (J) and stepped up or down in 5 to 10 joule increments depending on the success and limitations of the generator used.

RESULTS::

Successful acute defibrillation using ≤35 J was noted in 100% of left mid-axillary PG subjects (n=27, mean 16.3±8.6 J) and 83% of left pectoral PG subjects (n=6, mean 21.0±8.4 J). Furthermore, 24 of 27 (89%) of patients tested with a left, mid-axillary intermuscular PG had successful VF conversion with defibrillation energies at least 10 J below the maximum delivered output of the device. All evaluable episodes (n=93) were automatically sensed, detected, and shocked. No serious device-related intraoperative adverse events were observed.

CONCLUSIONS::

This first-in-human study documented the safe and reliable placement of a novel extravascular ICD lead with effective sensing and defibrillation of induced ventricular fibrillation using commercial DF-4 ICD PGs.

2019-07-01·Circulation. Arrhythmia and electrophysiology1区 · 医学

Feasibility of an Entirely Extracardiac, Minimally Invasive,Temporary Pacing System

1区 · 医学

Article

作者: Marcovecchio, Alan ; Burke, Martin C. ; Quast, Anne-Floor B.E. ; Sanghera, Rick ; Vehmeijer, Jim T. ; Beurskens, Niek E.G. ; Wasley, Richard ; Ebner, Adrian ; Knops, Reinoud E.

Background::

A completely extracardiac pacing system provides the potential for clinical advantages over existing device alternatives that require intravascular, endocardial, or epicardial contact. Preliminary studies evaluating the feasibility of cardiac pacing with a lead in the anterior mediastinum, outside the pericardium and circulatory system have been completed. These studies examined (1) the anatomic access route, (2) the usability of a delivery tool to facilitate lead placement, and (3) the pacing performance of the extracardiac lead.

Methods::

Feasibility evaluations included (1) a retrospective computed tomography analysis to characterize anatomic variations related to lead access, (2) accessing the anterior mediastinum in cadavers and human subjects using a custom delivery tool, and (3) acute clinical pacing performance.

Results::

Major findings: (1) A total of 166 (95%) out of 174 patients had a viable lead access path through the fourth, fifth, or sixth intercostal space. (2) Access to the targeted implant location using a delivery tool was successful in all 5 cadavers and 3 humans without use of fluoroscopy and with an average lead delivery time of 121±52 s. No damage to the lung, pericardium, heart, or internal thoracic vessels occurred. (3) Pacing performance was tested in 6 human subjects showing a threshold voltage of 4.7 V (2.7–6.7), threshold pulse width of 1.8 ms (1.0–2.5), and an impedance of 1205 Ω (894–1786). R-wave amplitudes measured 9.6 mV (5.6–12.0).

Conclusions::

Results support the feasibility for this completely extracardiac pacing method in a heterogeneous patient population, using a minimally invasive, parasternal, delivery approach and with adequate sensing and thresholds suited for temporary pacing.

项与 AtaCor Medical, Inc. 相关的新闻（医药）

2024-05-12

·动脉网

无需透视引导、可实现血管外起搏，它凭此融了两个亿

作为威胁人类生命健康的“头号杀手”，心血管疾病的发病和死亡人数依旧保持着增长趋势。《中国心血管健康与疾病报告2022》指出，由于我国居民不健康生活方式流行，有心血管病危险因素的人群巨大，人口老龄化加速，我国心血管病（CVD）发病率和死亡率仍在升高，疾病负担下降的拐点尚未出现。其中，心力衰竭、心律失常等患病率的增加提升了对于心脏起搏器的需求。弗若斯特沙利文指出，全球进行的心脏起搏器植入手术的数量预期将由2021年的1.3百万台增加至2030年的1.7百万台，复合年增长率为3.0%。预期中国的心脏起搏器植入手术增长率最高，2021年至2030年的估计复合年增长率为7.6%。从市场规模来看，全球心脏起搏器市场预期将由2021年的3,597.4百万美元增加至2030年的4,224.9百万美元，复合年增长率为1.8%。中国预期将成为增长最快的心脏起搏器市场，2021年至2030年的估计复合年增长率为5.7%。虽然，心脏起搏器技术在维持心脏正常节律、提高泵血能力等方面意义重大，但同时也具有相应的并发症。尤其是需要经过静脉系统植入的导线，可能会造成静脉栓塞、重度三尖瓣反流、电极损伤、感染等。而位于美国加利福尼亚州的AtaCor Medical则致力于改变这一问题，创新并提高心律管理的医疗标准。它开发了一种完全心外、微创的临时起搏系统，该技术已经完成了早期临床评估，将为需要心动过缓起搏支持的患者提供更优的替代治疗选择。减少对经静脉ICD导线的依赖并避免并发症在进行传统起搏器治疗时，起搏硬件会被插入患者的静脉中并附着在心脏内部，这一过程需要大量的X射线成像。一旦植入，这些硬件可能导致严重的并发症，如感染、血管或心脏损伤、设备故障等。并且移除程序也十分具有挑战性，即使是对于较为新颖的“无导线”起搏器也是如此。此外，用于紧急情况或计划手术中的临时起搏导线，通常会强制患者卧床休息。最近，一种皮下ICD系统问世。但由于需要更高的冲击能量，该系统需要更大的脉冲发生器，并且缺乏其他功能，如心动过缓和抗心动过速起搏疗法。成立于2014年的AtaCor Medical正在改变心脏起搏方式。通过将导线定位在心脏和静脉结构之外，AtaCor的目标是减少对经静脉ICD导线的依赖并避免与之相关的急性和长期并发症。AtaCor的新型 EV-ICD 导联设计用于提供电击和抗心动过速起搏疗法，以治疗快速性心律失常。AtaCor的胸骨下起搏导线无需医学成像即可插入，允许更快、侵入性更小的治疗。独特的放置位置避免了进入患者血管系统的需要，并且完全不接触心脏。此外，胸骨下导线能够消除与临时起搏相关的卧床限制，从而改善患者的活动能力和术后恢复。据AtaCor Medical称，AtaCor EV 临时起搏导联系统是同类产品中的首创，也是唯一一种完全不触及心脏和血管系统的植入式临时起搏系统。无需进入心脏、血管系统即可提供临时起搏AtaCor EV 临时起搏导联系统旨在为新发心律失常的稳定起搏提供支持，以帮助指导治疗决策和优化患者护理，并对传导障碍进行评估，以确定是否需要永久起搏。AtaCor EV临时起搏导联系统在设计时充分考虑了人体心胸部的解剖结构，从而确保了起搏过程的精确性，并保护患者的血管系统不受损伤。作为新一代心脏起搏器系统，它无需进入心脏、血管系统或导管室即可提供临时起搏，消除了经静脉导线和经皮起搏的并发症，减轻了患者的不适感。该系统利用解剖标志，使临时起搏导线能够在需要的时间和位置进行传递，而无需经过透视引导。系统采用专有的胸骨旁方法，使定制的起搏导线通过肋间隙插入并植入肋骨和心包之间的结缔组织，所有的操作都通过胸骨边缘的2到3厘米小切口完成。AtaCor EV 临时起搏导联系统采用专有的胸骨旁方法起搏导线的远端包含两个电极，位于心包附近左肺心切迹区域的心外组织中。起搏导联的近端包含电触点，可连接到起搏系统分析仪或临时起搏器。值得注意的是，该导线可连接到任何商用外部临时起搏器。在AtaCor EV 临时起搏导联系统中，StealthTrac导线是系统中用于心脏起搏器的导线，可进行双极感测和起搏，能监测心脏的电活动，并根据需要提供电脉冲来调节心跳，提供了稳定的捕获和感测性能。MACH I 送导工具则用于将心脏起搏器的导线传送到心外膜区域。通过一个小切口将导线安置在前纵隔，这是一个位于胸骨后方的区域，而不是传统的心脏内部或心包膜上。此外，它还可以连接到皮下临时起搏器，用于短期院外起搏，以及定制的皮下永久起搏器，满足慢性起搏需求。 AtaCor EV 临时起搏导联系统具体而言，AtaCor EV 临时起搏导联系统具有以下几大优势：第一，具有“血管外安全性”。采用血管外起搏系统降低了传统方法中存在的风险、成本和局限性。其潜在的临床优势避免了与传统临时起搏相关的风险，如全身性感染、血栓栓塞、心脏穿孔、心包积液和心包填塞。第二，可实现快速无影像递送。AtaCor EV临时起搏导线的递送避免了传统方法中需要X射线引导的步骤，可直接通过外血管路径插入导线，从而缩短了治疗时间；第三，减少患者不适。相比于经颈静脉或股静脉进入的传统起搏方法，在不引起患者不适、也不刺激骨骼肌的情况下可以迅速、可靠地恢复心脏节律。第四，减少卧床限制。外血管植入设计旨在加速患者康复，缩短住院时间。可支持术后患者行走，减少卧床时间，将患者转移到非ICU病床进行延长评估，减少对 ICU 观察和相关护理资源的需求，降低护理成本。第五，TAVI 期间和之后简化患者管理。随着TAVI（经导管主动脉瓣植入）手术的增加，AtaCor EV临时起搏导联系统致力于在主动脉瓣部署期间和术后评估心脏传导障碍时，提供稳定的体外和心外起搏支持。已将AtaCor EV-ICD导联系统拓展至电击除颤AtaCor Medical的管理团队由植入式心脏设备和电生理学领域的资深专家组成，他们拥有80多年的综合经验。总裁兼首席执行官Rick Sanghera拥有超过25年的植入式心脏设备的知识积累和经验，从 21 岁开始在 Guidant 公司内部担任工程师，24岁时随公司进行一线工作。在这段经历中，Rick Sanghera意识到植入式心脏设备有优化和创新的潜力。“我们总有办法制造出更好的设备，让医生更轻松地治疗病人，让病人不再一直感觉自己是病人”，秉持这一理念，他加入了Cameron Health 团队，开发出世界上首款无需在心脏上连接任何导线/电线的植入式皮下ICD（S-ICD），迄今为止已使得数以万计的患者免受了心源性猝死的威胁。2012年，公司被波士顿科学公司收购。随后，Rick Sanghera又与他人共同创立了 AtaCor Medical，继续致力于为医生和患者提供更为简单容易的心脏设备疗法。目前，公司也在将AtaCor EV 临时起搏导联系统应用于更加广泛的心脏治疗当中，除了用于提供起搏 ATP 之外，AtaCor Medical也正在将这一导联系统用于电击除颤，且所有步骤都无需接触心脏。这一应用正在研发中，旨在通过其独特的定向导联提供可靠的体外感测和除颤功能。该系统同样采用简化的胸骨旁入路方法。Atical EV-ICd 导联系统采用熟悉的外侧装置袋，以精简的隧道技术为特色，可与带有 df4 连接器的市售 ICD 兼容。2024年4月24日，AtaCor Medical宣布已完成2800万美元（约合人民币2.02亿元）的C 轮融资。本轮融资由Arboretum Ventures 领投，现有投资者 Longview Ventures、Hatteras Venture Partners、Catalyst Health Ventures 和 BayMed Venture Partners 也参与其中。公司计划利用融资所得资金支持FDA提交其血管外临时起搏导联系统以及完成第三代 EV-ICD 导联系统的试点研究。未来，Atacor Medical将继续利用其专有的血管外心律管理系统来革新心脏起搏和除颤的导联技术，实现既可提供传统的经静脉植入式心脏除颤和临时起搏设备的全部优点，又无需在心脏或血管系统中放置导线或装置，从而保持心脏的完整性并满足患者新的心脏护理需求。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

临床研究

2024-04-24

·PRNewswire

ATACOR MEDICAL CLOSES $28M SERIES C FINANCING TO DELIVER NEXT GENERATION EXTRAVASCULAR ICD AND PACING OPTIONS FOR CARDIAC RHYTHM MANAGEMENT

Funding Supports Regulatory Submissions and Clinical Milestones for Proprietary Extravascular (EV) Pacing & Implantable Cardioverter Defibrillator (ICD) Lead Systems SAN CLEMENTE, Calif., April 24, 2024 /PRNewswire/ -- AtaCor Medical Inc., a privately-held medical device company delivering the next generation of extravascular leads to advance the care of cardiac rhythm management (CRM) patients, announced today that it has completed a $28M Series C financing round. The new financing was led by Arboretum Ventures and includes existing investors Longview Ventures, Hatteras Venture Partners, Catalyst Health Ventures, and BayMed Venture Partners. AtaCor plans to use the new funds to support FDA submission for its extravascular temporary pacing lead system as well as completion of a pilot study for the third generation EV-ICD lead system. Continue Reading "Arboretum Ventures is thrilled to lead this round and collaborate with the world class team at AtaCor in their efforts to deliver pioneering EV cardiac rhythm management solutions. The AtaCor technology has the potential to significantly improve the lives of millions that rely on pacemakers and ICDs for life sustaining rhythm management," shared Jan Garfinkle, Founder and Managing Partner at Arboretum Ventures. Funds support FDA submission for EV temporary pacing lead system and a pilot study for the third generation EV-ICD lead system Post this "We welcome the Arboretum team to AtaCor and look forward to having Jan's expertise and guidance in the boardroom," said Rick Sanghera, CEO of AtaCor Medical. "As we plan for our upcoming clinical and regulatory milestones, this investment supports efforts that will bring AtaCor's novel products to patients." AtaCor's proprietary EV cardiac pacing and defibrillation lead systems are being designed to provide critical CRM therapy without placing any hardware inside the patient's heart; leaving the heart untouched and protected for future care needs. In addition, the AtaCor solution will allow for: Temporary pacing lead placement without the need for medical imaging for faster, less-invasive therapy delivery; and EV-ICD lead designs that use existing, commercially available ICDs, offering physicians flexibility in their device selection. AtaCor's EV-ICD and temporary pacing systems have been evaluated in several clinical studies and are designed to offer an important alternative treatment option for patients requiring bradycardia and implantable defibrillation therapies. "We are thrilled to partner with Arboretum Ventures on the next steps of AtaCor's development that expands its product platform of extravascular cardiac pacing and defibrillation," said existing investor and Board Chair, Maria Berkman of Longview Ventures. "Producing safe, effective, and readily deliverable EV ICD and pacing options continues to address a significant unmet need, and we are confident about AtaCor's promise to deliver novel solutions in this space." About AtaCor Medical, Inc. Atacor Medical is transforming cardiac pacing and defibrillation lead technology with its proprietary extravascular cardiac rhythm management system that provides the full benefits of traditional, transvenous implantable cardiac defibrillation and temporary pacing without placing leads or devices in the heart or vascular system; maintaining the integrity of the heart for future cardiac care needs. For more information, please visit . SOURCE AtaCor Medical Inc.

2022-11-03

·Business Wire

AtaCor Medical to Present Acute and 3 Month Results from Extravascular Implantable Cardioverter Defibrillator (EV-ICD) Studies

SAN CLEMENTE, Calif.--( BUSINESS WIRE )-- AtaCor Medical, Inc. has announced completion of its second human clinical study of the Extravascular Implantable Cardioverter Defibrillator (EV-ICD) Lead System. Building on acute data from the PASS PULL EV-ICD Study (n=18) completed in Q1-2022, the Sensing and Defibrillation with a Commercially Available ICD coupled with a Parasternal Extravascular Lead (SECURE EV) study (n=18) followed subjects with an AtaCor Medical EV-ICD lead connected to a commercially available ICD pulse generator for up to 3 months. Data from all 36 clinical study patients will be presented as a Late-Breaking Clinical Trial at the Asia Pacific Heart Rhythm Society ( APHRS ) Scientific Session 2022 in Singapore on November 20, 2022. AtaCor Medical’s novel EV-ICD lead is being designed to provide both shock and pacing therapies to treat life-threatening tachyarrhythmias when connected to commercially available ICD pulse generators. The lead is designed to be inserted at the left sternal margin through a rib space above the heart, leaving the heart completely untouched. Building upon the acute data previously collected in the PASS PULL EV-ICD study, the SECURE EV study evaluated chronic sensing and defibrillation with AtaCor’s EV-ICD lead while connected to a commercially available ICD pulse generator. All SECURE EV subjects received a concomitant transvenous ICD to allow direct comparison of sensing and detection between the traditional transvenous ICD System and an AtaCor Medical EV-ICD System. “We are excited to build upon our acute data with completion of 3 month follow-up visits in our first chronic defibrillation study,” remarked Rick Sanghera, AtaCor Medical’s CEO. “Our goal is to revolutionize the entire cardiac rhythm management industry, and this study is a significant advancement on that road.” Johan Aasbo, D.O., an investigator in the study, added, “The goal of AtaCor Medical’s EV-ICD lead and delivery system is to offer a novel, minimally invasive, and time efficient lead implantation modality built to connect to commercially available transvenous ICD pulse generators. It was my privilege to participate in the implantation, gathering, and analysis of the system's initial 90-day performance evaluation. This research will serve as the foundation for longer implant duration studies. The ultimate goal will be to evaluate the AtaCor Medical EV-ICD System as a viable option for sudden cardiac death risk mitigation.” About AtaCor Medical, Inc. Established in 2014, AtaCor Medical is transforming cardiac pacing and defibrillation. AtaCor Medical’s extracardiac pacing lead is designed to be inserted between the ribs and pericardium without the need for medical imaging, allowing for faster, less-invasive therapy delivery. AtaCor Medical’s EV-ICD lead is inserted in a similar location and is being designed to offer permanent defibrillation and pacing therapies for the treatment of life-threatening tachyarrhythmias and bradycardia. AtaCor Medical’s management team is comprised of seasoned experts from within the implantable cardiac device and electrophysiology fields, bringing over 80 years of combined experience to the company and its products. Current investors include Broadview Ventures, Hatteras Venture Partners, and Catalyst Health Ventures. At this time, AtaCor Medical’s extracardiac pacing and EV-ICD lead systems are under development, and not yet approved for sale in any geography. For more information, please visit www.atacor.com .

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