The primary objective of this study is to evaluate the safety and the electrical performances of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.

开始日期2022-09-01

申办/合作机构

Sorin Group Italia Srl

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2021-02-25·Circulation journal : official journal of the Japanese Circulation Society3区 · 医学

Exploring a New Systematic Route for Left Ventricular Pacing in Cardiac Resynchronization Therapy

3区 · 医学

Article

作者: Leclercq, Christophe ; Ziglio, Filippo ; Feuerstein, Delphine ; Ritter, Philippe ; Marquié, Christelle ; Ollivier, Jean-François ; Albatat, Mohammad ; Shan, Nicolas ; Anselme, Frédéric

BACKGROUND:

Frequency and distribution of left ventricular (LV) venous collaterals were studied in vivo to evaluate the ease and feasibility of implanting a new ultra-thin LV quadripolar microlead for cardiac resynchronization therapy (CRT).

METHODS AND RESULTS:

Evaluable venograms were analyzed to define the prevalence of venous collaterals (>0.5 mm diameter) between: (1) different LV segments; and (2) different major LV veins in: unselected patients who underwent CRT from 2008 to 2012 at Rouen Hospital, France (retrospective); and CRT patients from the Axone Acute pilot study in 2018 (prospective). In prospective patients with evaluable venograms, LV microlead implantation was attempted. Thirty-six (21/65 retrospective, 15/20 prospective) patients had evaluable venograms with ≥1 visible venous collaterals. Collaterals were found between LV veins in all CRT patients with evaluable venograms. Regionally, prevalence was highest between: the apical inferior and apical lateral (42%); and mid inferior and mid inferolateral (42%) segments. Collateral connections were most prevalent between: the inferior interventricular vein (IIV) and lateral vein (64% [23/36]); and IIV and infero-lateral vein (36% [13/36]). Cross-vein microlead implantation was possible in 18 patients (90%), and single-vein implantation was conducted in the other 2 patients (10%).

CONCLUSIONS:

Venous collaterals were found in vivo between LV veins in all CRT patients with evaluable venograms, making this network an option for accessing multiple LV sites using a single LV microlead.

2020-08-01·Contemporary clinical trials4区 · 医学

A prospective, multi-center randomized, controlled, blinded trial of vagus nerve stimulation for difficult to treat depression: A novel design for a novel treatment

4区 · 医学

Article

作者: Broglio, Kristine ; Rush, A John ; Kriedt, Christopher ; Conway, Charles R ; Aaronson, Scott T ; Sackeim, Harold A ; Bunker, Mark ; Vestrucci, Matteo ; Greco, Theresa ; Olin, Bryan

Few treatment options exist for patients with difficult-to-treat depression (DTD). One potentially efficacious treatment is vagus nerve stimulation (VNS): chronic stimulation of the vagus nerve using an implanted stimulator. Given a series of recent VNS clinical studies, including a large, five-year naturalistic investigation, the Center for Medicare and Medicaid Services (CMS) reconsidered the previous non coverage determination and announced coverage for patients participating in a "coverage with evidence" trial. This study, entitled, A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER), includes DTD patients with at least four unsuccessful antidepressant treatments in the current episode and will randomize both unipolar and bipolar DTD participants, each up to 500 evaluable enrollees. Predetermined interim analyses will define the necessary sample size. All participants will be implanted with VNS devices: half receive active stimulation during year one, and half receive delayed stimulation after year one. Participants will be followed for 5 years. This RCT is unique for DTD studies: 1) large sample size and long study duration (one year of controlled comparison); 2) use of a percent time in response as the primary outcome measure, given the chronic illness and its fluctuating course (vis-à-vis meeting a response criteria at a single time point); 3) inclusion of diverse measures of VNS impact on function, including quality of life, degree of disability, health status, and suicidality.

2019-09-01·Cardiovascular engineering and technology3区 · 工程技术

In-Vitro Pulsatile Flow Testing of Prosthetic Heart Valves: A Round-Robin Study by the ISO Cardiac Valves Working Group

3区 · 工程技术

Article

作者: Ieropoli, Ornella ; Saikrishnan, Neelakantan ; Pan, Ning ; Retta, Stephen M ; Chalekian, Aaron J ; Lee, Shouyan ; Joseph, Russell ; Wu, Changfu ; Vatanpour, Sepehr ; Steinseifer, Ulrich ; Mester, David ; Fraser, Rob ; Marquez, Salvador ; Weinberg, Craig

PURPOSE:

Hydrodynamic performance testing is one of the core in vitro assessments required by the ISO 5840 series of standards for all prosthetic heart valves. A round-robin study carried out in 2005 in accordance with ISO 5840:2005 revealed significant variabilities in prosthetic heart valve hydrodynamic performance measurements among the participating laboratories. In order to re-examine the inter-laboratory variability based on the "state-of-the-art" under ISO 5840-1 and 5840-2:2015, the ISO Cardiac Valve Working Groups decided in 2016 to repeat the round-robin study.

METHODS:

A total of 13 international laboratories participated in the study. The test valves were chosen to be the St. Jude Medical Masters Series mechanical valves (19 mm aortic, 25 mm aortic, 25 mm mitral, and 31 mm mitral), which were circulated among the laboratories. The testing was conducted according to a common test run sequence, with prespecified flow conditions.

RESULTS:

The study revealed improved, yet still significant variability among different laboratories as compared to the 2005 study. The coefficient of variation ranged from 7.7 to 21.6% for the effective orifice area, from 10.1 to 32.8% for the total regurgitant fraction, and from 14.7 to 45.5% for the mean transvalvular pressure gradient.

CONCLUSIONS:

The study revealed the ambiguities in the current versions of the ISO 5840 series of standards and the shortcomings of some participating laboratories. This information has allowed the ISO Working Group to incorporate additional clarifying language into the ISO 5840-1, -2, and -3 standards that are currently under revision to improve in vitro assessments. The results presented here can also be used by the testing laboratories to benchmark pulse duplicator systems and to train and certify testing personnel.

项与 Sorin Group Italia Srl 相关的新闻（医药）

2023-05-19

·NS Medical Devices

MicroPort CRM gets FDA approval for Alizea and Celea pacemaker systems

MicroPort CRM also secured approval for the pacemakers’ associated products like the Vega pacing leads, the SmartTouch XT tablet-based programmer, and the SmartView Connect Bluetooth home monitor Alizea and Celea pacemaker systems have AutoMRI mode and Bluetooth connectivity. (Credit: Robina Weermeijer on Unsplash) French cardiac rhythm management company MicroPort CRM has received approval from the US Food and Drug Administration (FDA) for its new line of next-generation implantable pacemakers Alizea and Celea. MicroPort CRM also secured approval for the pacemakers’ associated products like the Vega pacing leads, the SmartTouch XT tablet-based programmer, and the SmartView Connect Bluetooth home monitor. The cardiac rhythm management company, a subsidiary of MicroPort Scientific, said that the latest approved devices are the longest-lasting pacemakers for their size on the market today. Both offer a volume of 11cc and have a projected longevity of 13 years, said the company. Alizea and Celea have the MicroPort CRM’s proprietary AutoMRI mode designed to boost the safety and quality of life of patients during a magnetic resonance imaging (MRI) examination. The bluetooth-enabled devices have been approved for usage in 1.5 and 3 Tesla MRI scanners when implanted with the Vega pacing leads. MicroPort CRM president Benoît Clinchamps said: “MicroPort CRM has always been committed to providing medical devices with the most advanced technology and features to improve patient outcomes and reduce the burden on the healthcare system. “Alizea and Celea pacemakers, associated with the SmartView Connect home monitor, are a perfect example of our objective to improve the management of healthcare by reducing hospital visits while ensuring continuity of monitoring and follow-up. “These new pacemakers keep patients connected to their clinical team with secured and streamlined communication.” According to the cardiac rhythm management firm, the longevity of the pacemakers enhances the standard of care for patients and physicians and lowers costs of healthcare. Additionally, it saves patients from frequent pacemaker generator changes and associated risks like infections. The patients receiving Alizea or Celea also get the access to the SmartView Connect home monitor. SmartView Connect is said to automatically transmits reports to the cardiologist on the functioning of the system along with alerts about abnormal rhythms, such as atrial fibrillation. Last year, the company secured FDA approval for its EasyFinder cardiac electrophysiology diagnostic catheters, and PathBuilder transseptal puncture products.

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2023-05-18

·Mass Device

FDA approves next-gen MicroPort CRM pacemakers

The cardiac rhythm management subsidiary of MicroPort Scientific said its newly approved devices are the longest-lasting pacemakers for their size on the market today. They offer a volume of just 11cc and a projected longevity of 13 years. Additionally, the company also received approval for the associated Vega pacing leads, SmartTouch XT tablet-based programmer and SmartView Connect Bluetooth home monitor. MicroPort CRM said it marks a “significant achievement” for patient care. It also demonstrates the Clamart, France-based company’s commitment to the U.S. market. “MicroPort CRM has always been committed to providing medical devices with the most advanced technology and features to improve patient outcomes and reduce the burden on the healthcare system”, said Benoît Clinchamps, president of MicroPort CRM. “Alizea and Celea pacemakers, associated with the SmartView Connect home monitor, are a perfect example of our objective to improve the management of healthcare by reducing hospital visits while ensuring continuity of monitoring and follow-up. “These new pacemakers keep patients connected to their clinical team with secured and streamlined communication.” About the new MicroPort CRM pacemakers Alizea and Celea utilize the company’s AutoMRI mode to increase safety and quality of life when undergoing MRI examinations. Patients only need to visit their cardiologist once within 10 days before their scan to activate AutoMRI mode. Once programmed, upon entering the MRI field, the pacemaker automatically switches to AutoMRI mode. Following the exam, the devices revert back to initial settings to improve the workflow for patients and medical staff. MicroPort CRM’s SmartView Connect, a home monitor placed next to the bed, offers ease of use to an elderly patient population. It provides this age group with greater autonomy and involvement in their medical care. The monitor automatically and regularly transmits cardiologist-detailed reports on the functioning of the system. It also sends timely alerts about abnormal rhythms, like AFib, or alerts triggered by patients experiencing symptoms. “Since launching our first pacemaker more than fifty years ago, MicroPort CRM has continued to develop pioneering cardiac technologies, culminating with this FDA approval for the Alizea and Celea pacemaker systems,” said Aamir Mahmood, VP, Americas. “Our team has worked tirelessly to develop a device that not only improves patient outcomes but also provides convenience and peace of mind for patients and their families. The Alizea and Celea pacemakers, Vega pacing lead, SmartTouch XT programmer, and SmartView Connect remote monitor will make a significant difference in the lives of our patients.”

2023-05-18

·BioSpace

FDA Approves Next Generation MicroPort CRM AlizeaTM and CeleaTM Pacemaker Systems

Alizea™ and Celea™ are the world’s longest-lasting pacemakers for their size on the market today1 AlizeaTM and CeleaTM Pacemaker Systems feature AutoMRI™ Mode and Bluetooth®2 Connectivity CLAMART, France--(BUSINESS WIRE)-- MicroPort CRM, a global pioneer in the field of Cardiac Rhythm Management, headquartered in France, announced today it has received FDA approval for its latest range of implantable pacemakers, AlizeaTM and CeleaTM, the longest-lasting pacemakers for their size on the market today, as well as approval for its associated products the VegaTM pacing leads, SmartTouch XTTM tablet-based programmer, and SmartView ConnectTM Bluetooth® home monitor. This marks a significant achievement for patient care and demonstrates the company’s commitment to the United States market. AlizeaTM and CeleaTM feature the AutoMRI mode, a groundbreaking algorithm invented by MicroPort CRM, that increases patients’ safety and quality of life when undergoing an MRI examination. Patients only need to visit their cardiologist once within ten days before their MRI scan to activate the MRI mode. Once the mode is programmed, upon entering the MRI field, the pacemaker automatically switches to the MRI mode and following the exam reverts back to its initial settings which significantly improves the workflow for both patients and medical staff. These devices when implanted with the VegaTM pacing leads are rated for use in 1.5 and 3 Tesla MRI scanners3. At a volume of only 11cc and a projected longevity of 13 years4, Alizea™ and Celea™ are the longest-lasting pacemakers for their size on the market today. This leading innovation improves the standard of care for patients and physicians and reduces healthcare costs. Greater longevity in pacemakers saves many patients from having to undergo extra pacemaker generator changes and the risk of related complications such as infection. Patients implanted with AlizeaTM or CeleaTM are provided with the SmartView ConnectTM home monitor, which is placed next to their bed. The SmartView ConnectTM home monitor interface has been designed to be easy to use for an elderly patient population, providing this age group with greater autonomy and involvement in their medical care. The monitor automatically and regularly transmits to the cardiologist detailed reports on the functioning of the system, as well as timely alerts about abnormal rhythms, like atrial fibrillation, or alerts triggered by patients when experiencing symptoms. "MicroPort CRM has always been committed to providing medical devices with the most advanced technology and features to improve patient outcomes and reduce the burden on the healthcare system”, said Benoît Clinchamps, President of MicroPort CRM. “AlizeaTM and CeleaTM pacemakers, associated with the SmartView ConnectTM home monitor, are a perfect example of our objective to improve the management of healthcare by reducing hospital visits while ensuring continuity of monitoring and follow-up. These new pacemakers keep patients connected to their clinical team with secured and streamlined communication.” "Since launching our first pacemaker more than fifty years ago, MicroPort CRM has continued to develop pioneering cardiac technologies, culminating with this FDA approval for the Alizea™ and Celea™ Pacemaker Systems," said Aamir Mahmood, Vice President - Americas. "Our team has worked tirelessly to develop a device that not only improves patient outcomes but also provides convenience and peace of mind for patients and their families. The AlizeaTM and CeleaTM pacemakers, Vega pacing lead, SmartTouch XT programmer, and SmartView Connect remote monitor will make a significant difference in the lives of our patients." The approval of AlizeaTM, CeleaTM, and associated products is the latest in a number of FDA approvals for MicroPort in the U.S. Last year, MicroPort’s EasyFinderTM cardiac electrophysiology diagnostic catheters and PathBuilderTM transseptal puncture products received FDA approvals and will be distributed by the MicroPort CRM organization. About cardiac pacemakers Cardiac pacemakers are implanted in patients with an abnormally low heart rate (bradycardia), preventing them from leading a normal life. They are implanted under the skin, in the chest area, and are connected to the heart by transvenous leads that conduct electrical impulses to pace the heart and restore a normal heart rhythm. Patients implanted with a pacemaker must be regularly monitored by their cardiologist to ensure that the pacing system is working correctly. About MicroPort CRM MicroPort® CRM is a pioneering company in the field of Cardiac Rhythm Management (CRM), and a subsidiary of MicroPort Scientific Corporation (stock code: 00853.HK), with world headquarters in France. MicroPort® CRM is dedicated to improving the standard of care by bringing patients and physicians the most advanced cardiac technologies. Through its long-standing expertise, MicroPort® CRM develops, manufactures, and markets in more than 50 countries worldwide cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems, and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure. Its state-of-the-art products are manufactured in France, Italy, and the Dominican Republic. For more information, please refer to 1 : Longevity comparison developed using equivalent conditions and settings across manufacturers for device models under 14cc. Refer to manufacturers manuals. 2: Bluetooth is a registered trademark of Bluetooth SIG, Inc 3: Microport CRM MRI Solutions Manuals available online at microportmanuals.com 4: SafeR mode ON, assuming 50% atrial pacing and 5% ventricular pacing, 60 min-1, 2,5V, 0,35 ms, 750 ohms, sensors ON, Holter ON, Remote ON. Refer to Alizea and Borea user manuals available at microportmanuals.com.

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