catheter based News
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Acutus Medical to Present at the 21st Annual Needham Virtual Healthcare Conference
Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, announced today that its management team will present at the 21st Annual Needham Virtual Healthcare Conference on Tuesday, April 12, 2022 at 3:45 p.m. Eastern Time. A live webcast of the presentation may be accessed by visiting ...
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BioVentrix Announces Ralph Stephan von Bardeleben, MD, as Co- Principal Investigator of the REVIVE-HF Clinical Trial
BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, today announced that Ralph Stephan von Bardeleben, MD, of the University Medical Center of Mainz (Germany) has joined the European REVIVE-HF clinical trial of the Revivent TC™ Transcatheter Ventricular Enhancement System as co-principal investigator. Dr. von Bardeleben heads ...
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Showcase
Neurescue`s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest
COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market the company’s NEURESCUE® device for temporary occlusion of large vessels, including patients requiring emergency ...
By Neurescue
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Lungpacer Medical, Inc. Announces FDA Approval of Emergency Use Authorization of the Lungpacer Diaphragm Pacing Therapy System to Help Address COVID-19 Pandemic
Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today that the FDA has approved the Emergency Use Authorization for the use of the Lungpacer Diaphragm Pacing Therapy System (DPTS) to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure. According to the FDA ...
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BioVentrix Announces the Appointment of Cardiac Device Veteran Chris Wolff as Vice President of U.S. Sales
BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter Ventricular Restoration (TCVR), today announced that Chris Wolff has been named Vice President of U.S. Sales. In this role, Mr. Wolff will be responsible for driving enrollment in the ongoing ALIVE Trial studying the Company’s Revivent TC Transcatheter Ventricular ...
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BioVentrix Names Jim Dillon President and CEO
BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter-based Ventricular Restoration (TCVR), today announced that Jim Dillon has been named President and CEO. In his role, Mr. Dillon will be building BioVentrix into a high-performance heart failure therapy company, leading the team toward the achievement of its mission while ...
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BioVentrix Receives 2021 NUB Status 1 Reimbursement Renewal in Germany for the Revivent TC TransCatheter Ventricular Enhancement System
BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter based Ventricular Restoration (TCVR), today announced that the German Institute for Hospital Remuneration (InEK) has renewed the NUB Status 1 reimbursement designation in Germany for the Revivent TC™ TransCatheter Ventricular Enhancement System used in LIVE™ ...
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Valcare Medical Announces First-in-Human Transseptal Implant of the AMEND Annuloplasty Ring for Mitral Valve Repair
Valcare Medical Ltd. developer of transcatheter mitral and tricuspid valve repair and replacement solutions, announces that it has successfully completed its first-in-human transseptal delivery of the AMEND™ annuloplasty ring. The transseptal AMEND procedure was performed at the Schulich Heart Centre at Sunnybrook Health Sciences Centre in Toronto, under the Health Canada Special Access ...
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BioVentrix Announces Pivotal ALIVE Trial Resumes with First Patients Treated with LIVE Therapy Since COVID-19 Pause
BioVentrix, Inc., developer of the first hybrid transcatheter device for left ventricular remodeling after a heart attack, today announced that the Company has resumed cases in the pivotal ALIVE Trial studying Less Invasive Ventricular Enhancement, or LIVE™ Therapy, using the Revivent TC™ Transcatheter Ventricular Enhancement System. The first patient procedures completed since ...
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Procyrion, Inc. Wins Best Overall Medical Device Product in 2018 Medtech Breakthrough Awards
Procyrion, Inc., a medical device company developing a catheter-deployed micropump for the management of chronic heart failure, today announced that its AortixTM device won the MedTech Breakthrough Award for "Best Overall Medical Device Product." MedTech Breakthrough is an independent organization that recognizes the top companies, technologies and products in the global health and medical ...
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1 out of 10 survive cardiac arrest, a new device under FDA review hopes to change that
KEY POINTS Cardiac arrest is one of the leading causes of death in the U.S. and globally. It has a survival rate of 1 in 10 people with current treatment. The Neurescue device is designed to increase blood flow to the brain and heart during life-threatening emergencies such as cardiac arrest. Cardiac arrest is one of the leading causes of death around the world, ...
By Neurescue
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BioVentrix Announces Appointment of Accredited Public Company Director, Raymond W. Cohen, to its Board of Directors
BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure via Transcatheter Ventricular Restoration (TCVR), today announced the appointment of Raymond W. Cohen to the Company’s board of directors. Mr. Cohen, an accredited public company director, has nearly 40 years of experience leading and guiding a variety of private and publicly traded life ...
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Okami Medical Announces Closing Of $7.2M Series D Financing
Aliso Viejo, CA- June 24, 2020 – Okami Medical Inc., announced today the close of a Series D financing totaling $7.2 million. The financing was led by U.S. Venture Partners and was joined by members of Okami’s board of directors and medical device industry veterans. The financing provides Okami, the second portfolio company of medical device incubator Inceptus Medical LLC, with ...
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Cardiva Medical Announces $45 Million Financing Led by EW Healthcare Partners
SANTA CLARA, Calif., July 14, 2020 (GLOBE NEWSWIRE) -- Cardiva Medical, Inc, an innovator in the field of vascular closure, today announced the completion of a $45 million equity financing round. The equity round included new investor EW Healthcare Partners in addition to Cardiva Medical’s existing major investors, including affiliates of Luther King Capital Management, PTV Healthcare ...
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Saranas Launches Early Bird® Bleed Monitoring System in the U.S.
Saranas, Inc. today announced the commercial launch of the Early Bird Bleed Monitoring System in the United States. The Early Bird is the first and only device for the monitoring and early detection of endovascular bleed complications through a novel application of bioimpedance sensors. Saranas will demonstrate the device in Booth 1755 at the Transcatheter Cardiovascular Therapeutics (TCT) ...
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Medical Device Company Procyrion, Inc. Hires Three to Support Growth; Continues to Build
Procyrion, Inc., a medical device company developing a catheter-deployed micropump for the management of chronic heart failure, announced today it has hired three additional team members to support the advancement of its intra-aortic heart pump, AortixTM, for use in NYHA Class III-IV heart failure patients. Patricia DaSilva, Margo Fendrich, and Aaron Stone will focus on product development and ...
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BioCardia Receives No Objection Letter from Health Canada, Enabling Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada
BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has received a No Objection Letter from Health Canada, the country’s health services agency, allowing the CardiAMP® Heart Failure Trial to expand into Canada. The Phase III pivotal trial is currently enrolling ...
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CloudCath Announces Collaboration with American Renal Associates in Pre-Market Clinical Study for Peritoneal Dialysis Patients Innovative Remote Monitoring Platform Will Be Tested for In-Home Use
CloudCath, developer of a remote monitoring and predictive analytics platform for catheter-based treatments, today announced a collaboration with American Renal Associates (ARA), a leading provider of outpatient dialysis services. In a U.S.- based, pre-market clinical study, ARA will evaluate the use of CloudCath’s System by peritoneal dialysis (PD) patients. PD is a method of dialysis ...
By CloudCath
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Second Heart Assist Files Patent for Electro-Activated Shape Changing Impeller for Circulatory Assist Devices
Salt Lake City, Utah and Irvine, CA Nov. 17th, 2020 (PR Distribution) — Second Heart Assist, Inc. has filed a patent application with the United States Patent and Trademark Office (USPTO) covering numerous claims for the utilization of electro-active polymers and shape-memory nitinol in combination or on a stand alone basis to control, with electro-magnetic energy on demand, the shape and ...
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Acutus Medical completes enrollment in IDE trial with its AcQBlate FORCE Sensing Ablation System
Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced successful completion of patient enrollment in the company’s AcQForce™ Flutter Investigational Device Exemption (IDE) clinical trial which enrolled 110 patients at 21 sites globally. The AcQForce Flutter trial was designed to ...
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