Catheter Manufacturing System Articles & Analysis
37 news found
The medical device industry is undergoing a transformative period marked by groundbreaking innovations and advanced materials. As healthcare continues to evolve, the need for devices that enhance patient outcomes while ensuring safety and reliability is more critical than ever. Among the various materials used in medical device design, polytetrafluoroethylene (PTFE tubing) has emerged as a ...
Anteris Technologies (AVR) pauses trading as it plans for an upcoming capital raise On Thursday, the company entered a trading halt, pausing shares until Monday, August 2 It is unknown how much the company is planning to raise or where the funds will be spent On the market, Anteris last traded at $8.59 per share Anteris Technologies (AVR) has paused trading as it plans for an upcoming ...
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 ...
The Surfacer System received U.S. FDA De Novo clearance in February 2020. The Centers for Medicare and Medicaid Services (CMS) established a unique Healthcare Common Procedure Coding System (HCPCS) code for procedure associated with the use of the device (C9780) and assigned the procedure to a New Technology APC (1534) effective October 1, 2021 which has a ...
Volta Medical, a pioneering health tech company developing artificial intelligence (AI)-based software solutions to treat cardiac arrythmias, today announced the introduction of its leading-edge product, VX1, at three leading U.S. hospitals. New York Presbyterian Queens, Northwell Health’s Lenox Hill Hospital both in New York City, and Ascension St. Vincent’s Riverside, Jacksonville, ...
Using the Surfacer System, we were able to cross the patient’s central venous occlusion and obtain central venous access which facilitated the placement of a Hemodialysis Reliable Outflow (HeRO) graft and removal of their femoral catheter.” “Utilizing the Surfacer System to facilitate gaining central venous access and avoid the ...
The paper, published in the Journal of Vascular Access, demonstrated the ability to gain long-term vascular access without any significant complications or adverse events from the procedure with the benefit of avoiding the placement of a femoral catheter with its associated disadvantages. “This peer-reviewed paper further demonstrates the versatility the Surfacer ...
Acutus Medical, Inc. (Nasdaq: AFIB) (“Acutus”), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the initiation of AcQForce PFA-CE, a new clinical study that will evaluate the safety and performance of the company’s focal force sensing Pulsed Field Ablation (PFA) catheter and system in combination with ...
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the Centers for Medicare & Medicaid Services (CMS) has finalized a new Healthcare Common Procedure Coding System (HCPCS) code and New Technology Ambulatory Payment Classification (APC) assignment ...
Recently, Galaxy has also enrolled additional subjects in the ECLIPSE-AF study using the CARTO mapping system and CE-Marked catheters manufactured by Biosense Webster, achieving CENTAURI compatibility with the three market leading cardiac mapping systems and their associated catheters. ...
Q’Apel Medical products are already being utilized in over 185 hospital systems nationwide. Q’Apel is in the process of significantly increasing its manufacturing capacity and just recently announced moving into a 35,000 square foot facility to accommodate the growth. ...
Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, is pleased to announce and welcome Thomas Berryman as Chief Financial Officer. Tom has extensive experience in bringing venture funded medical technology companies from initial startup through product commercialization, revenue ...
Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), announced the results of its CryoCure-2 ultra-low temperature cryoablation (ULTC) prospective multi-center study in patients with AF at the 2021 Heart Rhythm Society Annual Meeting. The late-breaking clinical trials presentation was delivered by Dr. Tom De ...
SAN CARLOS, California, July 28, 2021 — Galaxy Medical announced today that the ECLIPSE-AF 90-day remapping data, presented at the Stanford BioDesign New Arrhythmia Technologies retreat, demonstrated durable lesions and chronic pulmonary vein isolation (PVI). Also, the company has recently treated patients in the same study using CE-Marked catheters and mapping systems from Boston ...
Q’Apel Medical products are already being utilized in over 185 hospital systems nationwide. This move supports Q’Apel’s plans to significantly increase its manufacturing capacity, add additional head count, and expand their product portfolio. ...
SAN CARLOS, California, July 22, 2021 — Galaxy Medical announced today that the 90 day remapping results of its ECLIPSE-AF study will be featured at the 2021 Stanford Biodesign New Arrhythmia Technologies Retreat on July 27th. Ante Ani, M.D., Electrophysiology Laboratory Director at University Clinical Hospital in Split, Croatia, and primary investigator of the study will deliver the ...
Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, is pleased to announce and welcome Jodie Fam as Vice President and General Manager, International. Jodie will be responsible for the leadership and development of International Sales for Q’Apel. Jodie brings more than 20 ...
SAN CARLOS, California, April 22, 2021 — Galaxy Medical announced today that the acute results of its Europe-focused ECLIPSE-AF study will be featured during the upcoming EHRA Congress in a innovative Technology presentation on April 25th by Ante Ani , M.D., Electrophysiology Laboratory Director at University Clinical Hospital in Split, Croatia, and primary investigator of the study. The ...
Prior the procedure described in the paper, the patient was implanted with a leadless pacemaker system due to unsuccessful attempts to gain central venous access using a recanalization procedure. ...
The following products will join the Vascular portfolio: Makoto Intravascular Imaging System, the only FDA-cleared dual-modality catheter and imaging system indicated for the detection of lipid core plaque (LCP) and the identification of plaque and patients at higher risk of MACE, from Infraredx, a Nipro company. Dualpro IVUS+NIRS Imaging ...