atHeart Medical's reSept ASD Occluder is designed to preserve patients' future transseptal treatment optionsBAAR, Switzerland and SANTA CLARA, Calif., June 18, 2024 /PRNewswire/ -- atHeart Medical, a medical device company establishing a new standard of care for atrial septal defects (ASDs) closure, today announced promising long and short-term clinical outcomes of its reSept ASD occluder, to be presented at the medical conference CSI Frankfurt.

Athert Medical的reSept ASD封堵器旨在保留患者未来的经中隔治疗选择，瑞士巴尔和加利福尼亚州圣克拉拉，2024年6月18日/PRNewswire/--Athert Medical是一家建立房间隔缺损（ASD）闭合治疗新标准的医疗器械公司，今天宣布其reSept ASD封堵器的长期和短期临床效果良好，将在法兰克福CSI医学会议上发表。

The data from three patient cohorts show positive efficacy and safety profile that contribute to a growing body of evidence about the innovative device's potential. reSept is the first ASD occluder with a bioresorbable, metal-free frame, designed to enable future transseptal treatment: a true evolution for patients that need transcatheter septal closure..

来自三个患者队列的数据显示出积极的疗效和安全性，这有助于越来越多的关于创新设备潜力的证据。reSept是第一个具有生物可吸收，无金属框架的ASD封堵器，旨在实现未来的经间隔治疗：对于需要经导管间隔闭合的患者来说，这是一个真正的发展。。

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The reSept ASD Occluder has a bioresorbable, metal-free frame

切除的ASD封堵器具有可生物吸收的无金属框架

A growing body of evidenceThe new reSept data to feature at CSI on June 19th include:

越来越多的证据表明，将于6月19日在CSI发布的新的reSept数据包括：

Positive ten-year outcomes from the first-in-human (FIH) trial showing long-term efficacy and safety of the device - to be presented by Dr. Kolja Sievert, from the CardioVascular Center Frankfurt (DE)

法兰克福心血管中心（DE）的Kolja Sievert博士介绍了首次人体试验（FIH）显示该装置长期有效性和安全性的十年积极结果

Promising two-year data showing complete closure in a case study from the University of Virginia (UVA) cohort of ASCENT ASD, the ongoing pivotal trial approved in the USA, Canada, France and Switzerland - discussed by Dr. Scott Lim, Professor of Medicine and Pediatrics at UVA

弗吉尼亚大学（UVA）ASCENT ASD队列的一项案例研究显示，为期两年的数据显示，这项正在进行的关键性试验已在美国、加拿大、法国和瑞士获得批准，该研究已完全结束，UVA医学和儿科教授Scott Lim博士对此进行了讨论

One-month reSept efficacy in patients with iatrogenic ASDs (iASDs), caused by mitral valve intervention, from the Canadian first-ever experience through Health Canada's Medical Devices Special Access Program - shown by Dr. Fady Zaky from St Paul's Hospital, Vancouver, (CA)

来自加拿大温哥华圣保罗医院的法迪·扎基博士（Fady Zaky）展示了加拿大首次通过加拿大卫生部医疗器械特别接入计划对二尖瓣介入引起的医源性ASD（IASD）患者进行为期一个月的疗效恢复

'Having pioneered reSept in its early days as part of ASCENT ASD in the USA, I am very pleased about the long-term outcomes from the earlier European FIH trial and the wealth of promising new data available,' said Dr. Saibal Kar, National Physician Director HCA Healthcare, USA, co-Principal Investigator of the ASCENT ASD trial.

ASCENT ASD试验的联合首席研究员、美国HCA Healthcare国家医师主任Saibal Kar博士说：“作为美国ASCENT ASD的一部分，我在早期开创了reSept，我对早期欧洲FIH试验的长期结果以及大量有希望的新数据感到非常高兴。”。

'They indicate how transcatheter ASD closure with a bioresorbable device could become an even less invasive procedure for patients long-term. This is a very exciting development for our patients.'To date around 100 patients with ASDs have been successfully treated as part of trials and special access iASD adult use in Canada, France, Germany, Switzerland and the USA.

“他们指出，使用生物可吸收装置进行经导管ASD封堵术如何成为长期患者侵入性更小的手术。这对我们的患者来说是一个非常令人兴奋的发展。”迄今为止，在加拿大、法国、德国、瑞士和美国，大约100名ASD患者已被成功治疗为试验和特殊途径iASD成人使用的一部分。

The ASCENT ASD pivotal study is currently enrolling patients in over 20 hospitals in the United States, four hospitals in France and will start treating patients in Canada and in Switzerland following Health Canada and Swissmedic's recent authorizations.'Around 100 patients have been implanted with reSept to date.

ASCENT ASD关键研究目前正在美国20多家医院、法国四家医院招募患者，并将在加拿大卫生部和瑞士医学院最近授权后开始治疗加拿大和瑞士的患者。”迄今为止，约有100名患者植入了reSept。

While hospitals continue to enroll patients as part of ASCENT ASD in several countries, we are excited that these positive outcomes showcase the potential for reSept to soon be the new standard of care,' said Laurent Grandidier, atHeart Medical CEO.The reSept ASD Occluder is an investigational device that aims to address the limitations of current occluders, which have metallic frames that stay in a patient's heart for life and can limit transseptal interventions.About reSept™ ASD OccluderreSept is the first ASD occluder with a bioresorbable, metal-free frame, designed to enable future transseptal interventions.

Athert Medical首席执行官劳伦特·格兰迪耶（LaurentGrandidier）说，虽然一些国家的医院继续招收ASD上升患者，但我们很高兴这些积极的结果显示了reSept很快成为新标准护理的潜力。。关于reSept™ASD封堵器reSept是第一个具有生物可吸收，无金属框架的ASD封堵器，旨在实现未来的经间隔干预。

Unlike existing occluders, its frame comprises two synthetic fabric patches connected by bioresorbable filaments that overtime resorb in the body.About reSept clini.

与现有的封堵器不同，它的框架由两个合成织物贴片组成，这些贴片由生物可吸收的细丝连接，这些细丝会在体内超时再吸收。关于reSept clini。

First-in-Human trial in Germany - nine adult ASD patients

德国首次人体试验-9名成年自闭症患者

European registry in Switzerland and Germany - six ASD patients, of which four children

瑞士和德国的欧洲登记处-六名自闭症患者，其中四名儿童

ASCENT ASD Pivotal trial – a prospective, single-arm, global multi-site clinical investigation approved by US FDA, French ANSM, Health Canada and Swissmedic; currently enrolling up to 250 patients, around 90 patients implanted to date. For more information: www.clinicaltrials.gov - Identifier: NCT04591392..

ASCENT ASD Pivotal试验-一项由美国FDA，法国ANSM，加拿大卫生部和Swissmedic批准的前瞻性单臂全球多地点临床研究；目前招募了250名患者，迄今为止约有90名患者植入。更多信息：www.clinicaltrials.gov-标识符：NCT04591392。。

About atHeart MedicalatHeart Medical is a medical device company with offices in Switzerland and the United States committed to establish a new standard of care for treatment of atrial septal defects (ASDs). For more information: www.atheartmedical.com.About ASDCommonly described as a 'hole in the heart', an ASD is an opening in the heart septum between the left and right atria.

关于Athert MedicalatHeart Medical是一家医疗器械公司，在瑞士和美国设有办事处，致力于建立治疗房间隔缺损（ASD）的新标准。欲了解更多信息，请访问www.athertmedical.com.About ASD通常被描述为“心脏中的孔”，ASD是左心房和右心房之间心脏隔膜的开口。

ASDs are the second most common congenital heart defect, affecting six in 10,000 births.1 They can also be the result of procedures, such as mitral valve treatment, that require crossing the septum (iASDs). A large atrial septal defect can cause extra blood to overfill the lungs and overwork the right side of the heart.

自闭症是第二大最常见的先天性心脏病，每10000名新生儿中就有6名患有自闭症。1自闭症也可能是需要穿过隔膜（IASD）的二尖瓣治疗等手术的结果。较大的房间隔缺损会导致额外的血液充满肺部，使心脏右侧过度劳累。

If not treated, it can lead to pulmonary hypertension, arrythmia, heart failure and increased risk of stroke.1 When ASDs require closure, the current standard of care is to implant a septal occluder with a metallic frame through a minimally invasive transcatheter procedure.SOURCE atHeart Medical.

如果不治疗，它可能导致肺动脉高压，心律失常，心力衰竭和中风风险增加[1]。当ASD需要闭合时，目前的护理标准是通过微创经导管手术植入带有金属框架的间隔封堵器。来源：Athert Medical。