cardiac event News
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Marizyme Announces New Distribution and Channel Partnership for Chilean Market with Abdera
Marizyme, Inc. (OTCQB:MRZM), a publicly traded global biotechnology company developing products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications, announced today that it has entered into a supply and distribution agreement with Abdera Financial, Inc., a Chilean based distributor, to distribute Marizyme's DuraGraft® ...
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StemBioSys participates in Biotech Showcase Digital during J.P. Morgan Week 2021
StemBioSys, Inc., a privately held biomedical company that manufactures and develops innovative, advanced human stem cell technologies to improve the predictive power of pre-clinical drug safety screening, today announced its President and Chief Executive Officer Bob Hutchens will participate in Biotech Showcase Digital being held January 11-15, 2021. During Biotech ...
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Elucid’s Next-Generation Plaque Analysis and FFRCT Technology to be Featured on 2022 AHA Scientific Sessions Program
BOSTON – November 4, 2022 – Elucid, Inc., a medical technology company providing physicians AI-powered imaging analysis software to characterize cardiovascular disease, has announced that the company’s technology will be featured on the program at the 2022 American Heart Association (AHA) Scientific Sessions, November 5-7, 2022 in Chicago. Elucid has developed FDA-cleared ...
By Elucid
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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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FFR-SEARCH Shows Clear Trend Towards Major Adverse Cardiac Events with Lower FFR
Dr. Roberto Diletti from The Erasmus Center in Rotterdam, Netherlands, presented the results of the two-year follow-up analysis of the FFR-SEARCH observational registry during the EuroPCR conference in Paris. The analysis evaluated the outcomes of patients and prognostic value of post-percutaneous coronary intervention (post-PCI) FFR assessment, indicating patients with a lower FFR post-PCI ...
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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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Infraredx, a Nipro Company, Announces FDA Approval of Expanded Label Claim for the Makoto Intravascular Imaging System
Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indications for use for its Makoto Intravascular Imaging System. The approval is based on the results of the landmark Lipid-Rich Plaque (LRP) Study, which demonstrated the ability of ...
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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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Marizyme Announces Approval for DuraGraft in India
Marizyme, Inc. (OTCQB:MRZM), a publicly traded global biotechnology company developing products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications, announced today that its flagship product DuraGraft® is now registered and licensed for import into India through Marizyme's distribution partner Regency Lifesciences. India ...
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MFDS Greenlights VUNO Med-DeepCARS, AI Medical Device for Cardiac Arrest Prediction
South Korean artificial intelligence (AI) developer, VUNO Inc. announced today that it has received regulatory approval from the Ministry of Food and Drug Safety (MFDS) for its VUNO Med®–DeepCARS™, an AI medical device for cardiac arrest prediction through vital signs. VUNO Med®–DeepCARS™ is a breakthrough AI-driven medical device that analyzes the potential risk ...
By Vuno Inc.
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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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Orchestra BioMed Announces Clinical Data Demonstrating a Significant and Sustained Reduction in Blood Pressure in MODERATO II Control Patients After Crossover to BackBeat Cardiac Neuromodulation Therapy
Clinically meaningful and statistically significant reduction in systolic blood pressure is consistent with the decrease previously observed in the study treatment group during the same time period. Ambulatory Systolic Blood Pressure (aSBP) decreased by an average of 10.3 mmHg (p Office Systolic Blood Pressure (oSBP) decreased by an average of 13.1 and 20.9 mmHg at 6 and 12 months, ...
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Celixir announces US FDA approval of the IND application for cell therapy Heartcell
FDA IND and UK MHRA CTA approval both achieved in H1 2018 Potentially pivotal heart failure trial of up to 250 patients in the UK and US Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for Heartcel, its immune-modulatory ...
By Celixir plc
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Marizyme, Inc. Appoints Veteran Business Executive Julie Kampf to Board
Marizyme, Inc. (OTCQB:MRZM), a publicly traded global biotechnology company developing products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications, announced today that it has named veteran business executive Julie Kampf as an Independent Member of its Board of Directors. "Ms. Kampf will provide invaluable guidance as an ...
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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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Orchestra BioMed Announces Clinical Data Showing Significant and Sustained Reduction in Systolic Blood Pressure Out to Two Years with BackBeat Cardiac Neuromodulation Therapy
Clinically meaningful and statistically significant reduction of 16.6 mmHg in systolic blood pressure out to two years 88% of the treated patients had isolated systolic hypertension (ISH) 70.6% of all treated patients and 80% of treated ISH patients had their blood pressure under control at 24 months Orchestra BioMed™, Inc., (“Orchestra BioMed” or the ...
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CTA approval for potentially pivotal Heartcel Phase IIb trial
Adult heart failure trial to complete in 2020 with potential market entry in 2021 Trial to be conducted at Imperial College London’s Royal Brompton, UK Celixir, a private company discovering and developing lifesaving regenerative medicines, today announced it has received formal clinical trial application (CTA) approval from the Medicines and Healthcare Products Regulatory Agency to ...
By Celixir plc
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Results of the PROSPECT II Natural History Study Demonstrate High-Risk Plaques Identified by NIRS+IVUS Imaging are Linked to Future Coronary Events
Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced positive results from the PROSPECT II and PROSPECT ABSORB studies, presented today as a late-breaking clinical trial at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation. The PROSPECT II study demonstrated the ability of near-infrared spectroscopy ...
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ELIXIR MEDICAL EXPANDS BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM
MILPITAS, Calif. – April 22, 2021 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced that the BIOADAPTOR randomized controlled trial (RCT) is expanding to centers in Belgium and Germany. The BIOADAPTOR RCT is evaluating the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel ...
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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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