coronary artery News
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CathWorks FFRangio System Receives Regulatory Approval in Japan
CathWorks today announced the approval of The CathWorks FFRangio™ System by the Japan’s Ministry of Health, Labour and Welfare (MHLW). The CathWorks FFRangio System is a non-invasive diagnostic technology that is used at the time of a routine angiography. The CathWorks FFRangio System transforms routine angiogram images into objective and comprehensive physiology information, ...
By CathWorks
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Kardiolytics’ VCAST Technology Offers Non-Invasive and Safe Solution for Functional Evaluation of Coronary Disease, According to Recent Study in Cardiovascular Engineering and Technology
Our latest publication in Cardiovascular Engineering and Technology showcases the feasibility and functionality of our VCAST technology, a patented, AI-based medical system developed for non-invasive, clinical quantitative and qualitative analysis of CT-scan data, to assess the hemodynamic significance of coronary artery atherosclerotic stenosis. Using a ...
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CathWorks FFRangio System Receives National Reimbursement Approval in Japan
CathWorks announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the application to provide reimbursement for the CathWorks FFRangio™ System, making it more broadly available for coronary artery disease decision-making in Japan. The CathWorks FFRangio™ System has already received regulatory approval from the Japanese Pharmaceuticals and Medical Devices ...
By CathWorks
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MagicTouch SCB Granted ‘Breakthrough Device Designation’ for the treatment of Small Coronary Artery Lesions.
Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed indication for use includes “The ...
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Mike Feher Appointed as CFO of CathWorks
CathWorks, a global leader of digital health innovation focused on helping patients with cardiovascular disease, announced today that Mike Feher was appointed Chief Financial Officer, effective immediately. An energetic and results-driven executive, Mr. Feher brings comprehensive strategic and operational finance experience to his role, including expertise in financial planning and analysis, ...
By CathWorks
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CathWorks FFRangio System Case Review - Highlight from Dr. Rahul Sharma’s CVIT Presentation
The CathWorks FFRangio System is revolutionizing treatment decisions for coronary artery disease with quick, non-invasive, wire-free 3D FFR guidance. In this excerpt from his webinar presentation at CVIT Japan 2021, Dr. Rahul P. Sharma, MBBS, FRACP, Director of Structural Interventions at Stanford Medical Center, presents a case study that demonstrates the highly accurate multi-vessel FFR ...
By CathWorks
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XyloCor Therapeutics Completes Oversubscribed $41.9 Million Series A Financing To Advance Novel Gene Therapy Pipeline For Coronary Artery Disease
Company closes additional $22.6 million in new financing Proceeds will fund initiation of new clinical trial for lead gene therapy candidate XC001 as adjunctive therapy for patients undergoing coronary artery bypass graft surgery XyloCor Therapeutics, a private clinical-stage biopharmaceutical company focused on the development of gene therapy for the significant unmet patient needs in ...
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Infraredx, a Nipro Company, Announces Enrollment of First Patient in EXPANSE PTCA study.
Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today the enrollment of the first patient in its EXPANSE PTCA study (NCT04985773) at the Cardiology Associates of North Mississippi in Tupelo, Mississippi. The study will be conducted in the United States with the objective to evaluate safety and effectiveness of the Lacrosse NSE ...
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XyloCor Therapeutics Doses Patients in Phase 1/2 Trial Evaluating Novel Gene Therapy XC001 in Refractory Angina
XyloCor Therapeutics today announced it has successfully dosed the first two patients in the EXACT Trial, a Phase 1/2 dose escalation trial evaluating the safety, tolerability and efficacy of its lead candidate XC001 in patients with refractory angina. The trial will enroll patients who are not responding to medication and are unsuitable for coronary artery bypass graft or percutaneous coronary ...
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Shockwave Medical and Genesis MedTech Obtain Regulatory Approval in China for Intravascular Lithotripsy
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, and Genesis MedTech Group announced today that they have successfully obtained approval from China’s National Medical Products Administration (NMPA) to market and sell the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheters ...
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ELIXIR MEDICAL ANNOUNCES OUTSTANDING 24-MONTH DATA FOR DYNAMX CORONARY BIOADAPTOR SYSTEM, DEMONSTRATING STRONG SAFETY WITH NO TARGET LESION REVASCULARIZATION, MYOCARDIAL INFARCTION OR THROMBOSIS THROUGH 24 MONTHS
MILPITAS, Calif. – January 27, 2020 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced the 24-month clinical results for the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology. The results were presented at the 30th Annual Live Interventions in Vascular Endotherapy ...
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ELIXIR MEDICAL ANNOUNCES COMMENCEMENT OF INFINITY-SWEDEHEART RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM
2,400-Patient Trial Utilizes Globally-Respected SWEDEHEART Registry Database in Randomized Study of First Metallic Device Treating Coronary Artery Disease That Adapts to Vessel Physiology MILPITAS, Calif. – March 16, 2021 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced commencement of the INFINITY-SWEDEHEART randomized ...
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Xeltis accelerating clinical trial program
Xeltis announced today that is planning to accelerate its clinical trial program for three restorative devices in parallel. CEO Eliane Schutte provided a sneak preview on Xeltis’ plans to an audience of investors and medtech companies at the Medtech and Diagnostics Forum organised by the investment bank Canaccord Genuity Capital Markets. Xeltis currently has three restorative devices in ...
By XELTIS BV
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BPA Linked to Coronary Artery Stenosis
According to the Huffington Post, a new study has found a correlation between bisphenol-A (BPA), a chemical that has been linked to cancer in animal studies and fetal development problems, and narrowed arteries, a condition called Coronary Artery Stenosis. BPA is commonly found in cans and plastic linings in food products. The Food and Drug Administration (FDA), has already banned the chemical ...
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ELIXIR MEDICAL ANNOUNCES FIRST PATIENT TREATED IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM
International Trial to Compare Bioadaptor, a Novel Coronary Artery Implant Designed to Adapt to Vessel Physiology, with Traditional Drug Eluting Stents International Trial to Compare Bioadaptor, a MILPITAS, Calif. – January 13, 2020 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced that the first patient has been treated ...
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B. Braun Interventional Systems Inc., an Affiliate of B. Braun Medical Inc., and Infraredx, a Nipro Company, Announce Strategic U.S. Collaboration to Execute the IDE Clinical Trial for the SeQuent Please ReX Drug Coated PTCA Balloon Catheter
B. Braun Interventional Systems Inc. (BIS) announced today that they will collaborate with Infraredx, a Nipro Company, to accelerate the U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trial for the B. Braun SeQuent Please ReX Drug Coated PTCA Balloon Catheter, which received FDA Breakthrough Device Designation in late 2019. This announcement furthers the ...
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Biomedical Catalyst Grant Award to Arterius Limited
Following the successful completion of the R&D project in 30th September 2016 (supported by a Smart award from the Innovate UK (TSB), Arterius has recently been awarded further funding from the Biomedical Catalyst-Early Stage programme to conduct the In-vitro and In-vivo GLP Evaluation of the Novel Bioresorbable Coronary Scaffolds; ArterioSorb. ArterioSorb is an innovative medical implant ...
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Elucid Eyes Big Opportunity to Save Lives with Software Amidst Major Guideline Changes
BOSTON–(BUSINESS WIRE)–Elucid, a medical technology company developing AI software to enable cardiovascular disease detection, expects newly issued guidelines will be a catalyst for non-invasive image, revolutionizing the way patients with coronary artery disease are diagnosed and treated. In a highly anticipated document published online yesterday in Circulation and the Journal of ...
By Elucid
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Soundbite Medical Enters Into A License Agreement With VFLO Medical To Bring Its Products To Greater China
Soundbite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific occlusive peripheral and coronary arterial diseases, today announced that it has entered into an exclusive license agreement with VFLO Medical (VFLO). Pursuant to the agreement, Soundbite has granted to VFLO an exclusive license for certain proprietary ...
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ELIXIR MEDICAL COMPLETES ENROLLMENT IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM
MILPITAS, Calif. – February 15, 2022 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced completion of enrollment in the BIOADAPTOR randomized controlled trial (RCT). The BIOADAPTOR RCT is evaluating the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology, allowing for ...
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