Atrial Septal Defects
An atrial septal defect (ASD) is a congenital heart defect that can occur when the septum, the wall that separates the left and right atria, does not form or close properly.
An atrial septal defect (ASD) is a congenital heart defect that can occur when the septum, the wall that separates the left and right atria, does not form or close properly.
Defects vary in size. Some may close on their own early in life, while others require an intervention. Today, the vast majority are performed through minimally invasive catheter-based interventions. They consist in implanting an atrial septal occluder through a transcatheter procedure to close the defect.
Current ASD occluder devices have dense metal frames that permanently clamp the septum. The long-term presence of metal in the heart may lead to potential complications and may limit future interventions that require crossing the interatrial septum.
The Best Device is Less Device.
The reSept ASD Occluder is the first occluder with a metal-free, bioresorbable frame designed for the closure of atrial septal defects.
Delivered through a 12F sheath and over a standard guidewire, the low-profile device features bioresorbable filaments connecting two polyester fabric patches, which contain radiopaque markers.
The device is fully deployed with the guidewire in place, providing the opportunity to reattach and reposition when necessary.
After endothelialization, the filaments slowly resorb, with complete resorption demonstrated in-vitro at 24 months. The polyester fabric and the radiopaque markers remain, which may be useful for future transseptal procedure planning. Available in three sizes, the device supports closure of defects from 8-22mm.
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Fabien’s successful track record in medical device development is the result of a forward-thinking mindset and strategic technical planning.
Fabien joined atHeart Medical as Vice President R&D in March 2023, leading the team driving forward the atHeart Medical R&D for next generation devices.
Fabien boasts a comprehensive 20-year background in project management, spanning across various facets from materials to the development of products. Prior to atHeart Medical, Fabien held leadership roles at startups in structural heart devices and biomaterials, including Symetis (acquired by Boston Scientific), Foldax (polymeric heart valve) and Open Stent Solutions (transcatheter mitral valve). In addition, Fabien’s career extended to well established companies such as Vascutek/Terumo and Datascope. His professional journey has taken him to multiple European countries, Australia and the United States.
A Mechanical Engineer graduate from University of Toulon, France and from University of West Scotland in Paisley, UK, Fabien gained his master’s degree in Polymer Science at University of North London, UK. He is main inventor or co-inventor of 15 patents granted between 2016 and 2022.
Scott is a veteran regulatory affairs executive with a proven track record in successful global regulatory strategies.
Alex’s broad range of expertise in operations and operations quality results from 30 years in the cardiac and cardiovascular medtech industry.
Alexander is Vice-President of Operations at atHeart Medical since May 2022. He has been with the company in a consulting role since it began operations in 2020.
With a drive for accomplishments and a strong compliance attitude, Alex has a remarkable experience spanning from manufacturing to clinical project management, from sales and business development to quality assurance.
Alex previously worked in-house at major corporations, such as Abbott and Guidant, and at start-up companies such as Xeltis. More recently, he also worked in the medtech industry as a consultant.
Alexander holds a biomedical engineering degree from Technical University Ulm, Germany.
Maureen’s expertise is setting up quality systems for successful start-up organizations.
Maureen is Vice-President of Quality for atHeart Medical since April 2022. She joined the company, bringing over twenty years of distinguished quality experience in multiple, prominent cardiovascular medical device start-ups such as Twelve and Ardian.
She has previously worked both in-house and as a consultant for a number of medical device companies that have been acquired by major medical device corporations, including Medtronic.
A biomedical engineer graduate from Marquette University in Milwaukee, WI, Maureen contributed to the development of intellectual property for systems and methods related to prosthetic heart valve devices.
In her spare time, she is also a Court Appointed Special Advocate (CASA) – volunteering to enrich the lives of kids in foster care.
Laurent is a global medtech executive with talent for turning research projects into commercially viable companies.
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Cookie & Privacy Policy
atHeart Medical Privacy & Cookie Policy governs the collection, processing and use of your personal data, when you visit and/or interact with our website.
This website privacy & cookie policy (“Website Privacy & Cookie Policy”) applies to the website www.atheartmedical.com and/or other atHeart Medical websites (each including any subpages) (“Website”) which are operated by atHeart Medical, Bahnhofstrasse 9, 6340 Baar, Switzerland (“atHeart Medical” or “we”). Other websites connected directly or indirectly with our Website, e.g., by hyperlinks, do not fall within the scope of this Website Privacy & Cookie Policy, whether or not they are operated by AtHeart Medical, an affiliated group company or partner.
This Website Privacy & Cookie Policy governs the collection, processing and use of your personal data, when you visit and/or interact with our Website, and explains our practices with respect to the placement of cookies, including the types of cookies we use and how you can manage them.
Website Privacy & Cookie Policy last revised on 11 March 2021.
1. Collection, Processing and Use of Your Personal Data
1.1. Anonymous Usage of our Website
You are welcome to visit our Website while remaining anonymous and without revealing any of your personal data.
However, when you first visit our Website we will ask for your consent to place cookies on your device and to track your website usage behaviour. This helps us to better understand how our customers use our Website and to improve our website offering and services.
If you do not agree with the above practices and wish to remain fully anonymous, you can indicate not to provide your consent. In this case, we will only collect certain anonymous information which do not directly relate to your person. For example, we may collect the number of visitors to our Website, browsing patterns and areas of interest. We analyse this information to understand how the visitor of our Website use it, and to assess trends, statistics and our customers’ needs, which help us to improve our Website.
Other than as indicated above, we will only collect your personal data if you voluntarily decide to share such information with us, such as by sending an enquiry via our contact form. Unless you have provided your explicit consent, and unless indicated otherwise in this Privacy Policy, we will use the personal data that you have shared with us only as necessary for enabling your use of our Website, including handling your requests. Apart from that, we may use any personal data we receive only in anonymized form (i.e., in a non-personally identifiable form which does not allow for any conclusions as to your identity) for statistical purposes and for internal evaluation how to improve our products and services. Your data will not be processed for other purposes or beyond the scope of this Privacy Policy, except where expressly permitted or required by applicable law.
1.2. Using our Contact Form
We collect the personal data you voluntarily disclose when you contact us through the contact form on our Website, for example, if you send us an enquiry. Unless indicated otherwise in this Website Privacy & Cookie Policy, your data will not be used without your consent other than to handle your request/enquiry, and not be used for any other purpose, unless expressly permitted or required by applicable law.
Your request/enquiry will be handled by atHeart Medical or, as necessary, by one of our local affiliated group companies responsible for handling the topics addressed in your request/enquiry for your jurisdiction.
2. Cookies
2.1. Essential cookies
Cookies are small text files that our Website asks to place on your computer or other internet enabled devices, such as tablets or smartphones. If your browser is set to accept cookies, then your browser adds the text in a small file.
Except as indicated otherwise in this Website Privacy & Cookie Policy, the cookies used by us are essential for the functioning and performance of our Website, such as by making our website work more efficiently and facilitating your use of the functionalities and services. We will not use the information stored in essential cookies for any other purpose than as strictly necessary to provide you with the services and functionalities requested.
2.2. Cookie Consent & Personalized Tracking
When you access our Website, we will ask for your consent to place additional cookies on your device by displaying a cookie banner (“Cookie Consent”). These cookies will not be strictly necessary for the functioning and performance of our Website but will help us to collect some of your personal data relating to your website usage behaviour in order to improve our website offering and services and/or to provide you with more personalized information and services.
The cookie banner informs you about the main purposes of the additional cookies and provides you with information about your choices and where you may access further information. Your continued use of our Website after having been displayed with the cookie banner will signify your consent to the described practices.
2.3. Other tracking technologies
We may also use other tracking technologies, such as pixels and web beacons in order to provide a better service. These technologies usually work in conjunction with cookies.
2.4. Managing your cookie settings
Most browsers are initially set to accept cookies. If you prefer, you can change your settings to generally refuse cookies, to delete cookies that have already been placed on your device, or to warn you before a cookie is placed. Please refer to your browser instructions or to www.aboutcookies.org or www.allaboutcookies.org to learn more about how to adjust or modify your browser settings.
If you choose not to accept cookies, this may impair the usability of the Website and you may not be able to take advantage of some of our features and services offered.
If you use different devices to access our Website (e.g., smartphone, tablet, computer, etc.) you will need to ensure that each browser on each device is adjusted to reflect your cookie preferences.
2.5. Use of Google Universal Analytics
This Website uses Google Universal Analytics (“Google Analytics”), a web analytics service provided by Google Ireland Limited, Gordon House, 4 Barrow St, Dublin, D04 E5W5, Ireland (“Google”). Google Analytics uses cookies to help us analyze how users use our Website, including the number of visitors to our Website, the websites our visitors have come from, and the pages they visit. This information is used by us to improve our Website offer and services. As a rule, any information generated by the cookie about your use of our Website will be transmitted to and stored by Google on servers in the United States.
Google will use this information as our commissioned data processor to help us evaluate the use of our Website, to compile reports on website activity and to provide other statistical and analytical services relating to usage of our Website. We use the Google anonymization function to change the last digits of your IP address. However, if you are logged in e.g. with a Google account, Google will be able to revoke the anonymization. In any event, atHeart Medical will never receive this information and cannot revoke the anonymization.
You may prevent the collection of data generated by the cookie about your use of this Website (including your IP address) and opt-out of being tracked by Google Analytics across all websites by downloading and installing a browser-plugin which is available here.
In this case, an opt-out cookie will be placed on your browser that prevents any further tracking of your use of this Website by Google Analytics. Please remember that you will have to opt-out again if you delete all cookies stored on your device.
You will also have to opt-out for each device you use to visit our Website.
3. YouTube
This Website also embeds YouTube videos provided by Google Ireland Limited, Gordon House, 4 Barrow St, Dublin, D04 E5W5, Ireland (“Google”). Using Google’s offering requires a connection to be established to Google’s servers in the US. During this process, certain information is transmitted to Google. AtHeart Medical does not control the collection, storage and use of any of your information by Google and does not have access to any information collected. You should read Google’s Privacy Policy carefully before you use any Google features.
Further information about how your data are collected and used by Google and your rights in relation to this can be found in Google’s privacy policy.
4. Disclosure of your Personal Data
AtHeart Medical is operating the Website as data controller. However, to ensure the customer relationship with you is handled efficiently, and to provide you with a good customer experience, your customer relationship may be managed directly by our Local Group Company located in your country when possible. The Local Group Company will be responsible for the related collection, processing and use of your personal data also as data controller. For instance, AtHeart Medical may share your personal data with the Local Group Company where this is necessary to answer specific requests or enquiries submitted by you through our Website. For these purposes, the Local Group Company will be granted with access to your personal data stored by AtHeart Medical and will collect, store, process and use such personal data on local level for the above purposes.
In addition, AtHeart Medical and/or the Local Group Company may use external technical service providers which are authorized to provide services on its behalf and in accordance with its instructions. These entities may have access to your personal data but only to the extent necessary to enable your use of our Website, including handling your requests or enquiries. For instance, AtHeart Medical (and/or, as applicable, the Local Group Company) may use service providers to host our Website, store your personal data, or analyze the information collected as explained in Section 2. These service providers may not disclose your personal data to any unauthorized third parties or use your personal data for any purposes other than as instructed. Some of these service providers may be located in countries outside Switzerland and the EU/EEA which may not provide for the same level of data protection as in your country of residence.
Other than as indicated above, we will not provide your personal data to any third party without your prior consent, unless we are compelled by law to do so.
5. Storage of your Personal Data and Data Security
AtHeart Medical and/or, as applicable, the Local Group Company may use cloud service providers located in countries outside Switzerland and the EU/EEA, including the United States of America (USA), to host and process your personal data for storage and communication. While the laws of those countries may not provide for the same level of data protection as considered adequate in Switzerland or the EU/EEA, we have taken the necessary measures to ensure your personal data will be handled and protected appropriately and only be processed on our behalf and in accordance with our instructions.
We will treat your personal data confidential. We have implemented appropriate technical and organizational security measures to protect your personal data against unauthorized disclosure or access, alteration, misuse, accidental or unlawful destruction or loss.
6. Your Rights / How to Contact Us
As per the provisions of applicable local data protection law, you have the right to request information as to what data we hold about you. In addition, where appropriate, you have the right to request the correction, deletion and/or blocking of your personal data and/or to restrict and/or object to the processing of your personal data for legitimate reasons as well as the right to data portability.
You may further at any time, with effect for the future, withdraw any consent you have given. For this purpose, please make use of the opt-out mechanisms provided for the different services (please see the respective descriptions in the corresponding Sections of this Website Privacy & Cookie Policy) or, with respect to your newsletter registration, you can also contact us per email as indicated below.
In case of any questions about the collection, processing and/or use of your personal data or to exercise your rights please send us an email at info@atheartmedical.com
7. Changes to this Website Privacy & Cookie Policy
We reserve the right to make changes to this Website Privacy & Cookie Policy at any time with effect for the future. The then current version of this Website Privacy & Cookie Policy will be made available on the Website. While we do not intend to make changes to this policy very often, it is always a good idea to double check our most current policy statement when you visit us to be sure that you have read and agree with what information we collect, how we use it and under what circumstances we disclose it.
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