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Coronary System Articles & Analysis

13 news found

Shockwave Medical and Genesis MedTech Obtain Regulatory Approval in China for Intravascular Lithotripsy

Shockwave Medical and Genesis MedTech Obtain Regulatory Approval in China for Intravascular Lithotripsy

(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 ...

ByShockwave Medical Inc.


Miracor Medical starts 2nd randomized study, targeting expanded indications

Miracor Medical starts 2nd randomized study, targeting expanded indications

Miracor Medical SA (Miracor Medical) today announced the first patient enrolled in the PICSO-AMI-V study to evaluate the benefits of PiCSO® (Pressure-controlled intermittent Coronary Sinus Occlusion) therapy as an adjunct to conventional primary percutaneous coronary intervention (PCI) for patients presenting with inferior ST-Elevation Myocardial Infarction ...

ByMiracor Medical SA


ELIXIR MEDICAL COMPLETES ENROLLMENT IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL COMPLETES ENROLLMENT IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

The BIOADAPTOR RCT is evaluating the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology, allowing for the restoration of normal vessel functions essential to cardiovascular performance. ...

ByElixir Medical Corporation


ELIXIR MEDICAL EXPANDS BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL EXPANDS BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

The BIOADAPTOR RCT is evaluating the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology. ...

ByElixir Medical Corporation


ELIXIR MEDICAL ANNOUNCES COMMENCEMENT OF INFINITY-SWEDEHEART RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL ANNOUNCES COMMENCEMENT OF INFINITY-SWEDEHEART RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

– March 16, 2021 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced commencement of the INFINITY-SWEDEHEART randomized controlled trial (RCT) of the DynamX™ Coronary Bioadaptor System, the first metallic coronary artery implant that adapts to vessel physiology. ...

ByElixir Medical Corporation


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

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

– 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. ...

ByElixir Medical Corporation


ELIXIR MEDICAL ANNOUNCES FIRST PATIENT TREATED IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL ANNOUNCES FIRST PATIENT TREATED IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

– January 13, 2020 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced that the first patient has been treated in the BIOADAPTOR randomized controlled trial (RCT) of the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel ...

ByElixir Medical Corporation


Results of the PROSPECT II Natural History Study Demonstrate High-Risk Plaques Identified by NIRS+IVUS Imaging are Linked to Future Coronary Events

Results of the PROSPECT II Natural History Study Demonstrate High-Risk Plaques Identified by NIRS+IVUS Imaging are Linked to Future Coronary Events

Several autopsy studies have found that lipid core plaque (LCP) is the underlying cause of most coronary deaths, and ruptured lipid cores are thought to cause most major adverse coronary events (MACE) in vivo. ...

ByInfraredx, Inc.


Orchestra BioMed Secures $20 Million Financing Facility from Silicon Valley Bank

Orchestra BioMed Secures $20 Million Financing Facility from Silicon Valley Bank

In June 2019, Orchestra BioMed also secured a $30 million payment and $5 million equity commitment as the upfront financial components of a global strategic partnership with Terumo Corporation to develop and commercialize Virtue® Sirolimus-Eluting Balloon (SEB), the first and only non-coated sirolimus-eluting angioplasty balloon system, in the percutaneous ...

ByOrchestra BioMed, Inc.


Miracor Medical granted FDA Breakthrough Device Designation for the PiCSO therapy

Miracor Medical granted FDA Breakthrough Device Designation for the PiCSO therapy

Food and Drug Administration (FDA) for its PiCSO Impulse System for treatment of STEMI patients. The FDA Breakthrough Device designation is intended to speed time to market for treatments of life-threatening or irreversibly debilitating diseases or conditions and recognizes the novelty of the PiCSO Impulse System and its potential to benefit patients with ...

ByMiracor Medical SA


Miracor Medical starts PiCSO-AMI-I randomized study in EU

Miracor Medical starts PiCSO-AMI-I randomized study in EU

Data from two recent studies (“PiCSO in ACS” and “OxAMI-PICSO”) showed that the use of the PiCSO Impulse System is associated with a significant infarct size reduction 1,2 . Furthermore, OxAMI-PICSO showed an early improvement of coronary microvascular function post PiCSO treatment. ...

ByMiracor Medical SA


FFR-SEARCH Shows Clear Trend Towards Major Adverse Cardiac Events with Lower FFR

FFR-SEARCH Shows Clear Trend Towards Major Adverse Cardiac Events with Lower FFR

“The FFR-SEARCH observational registry is an important clinical investment for ACIST, which builds upon the existing clinical evidence supporting the use of our Navvus Rapid Exchange FFR Microcatheter and RXi System in a variety of applications,” said Brad Fox, president and CEO, ACIST Medical Systems, Inc. ...

ByACIST Medical Systems


Miracor Medical closes final tranche of Series-D bringing the round to 30€M

Miracor Medical closes final tranche of Series-D bringing the round to 30€M

OxAMI-PICSO showed that the use of the PiCSO Impulse System is associated with an early improvement of coronary microvascular function. ...

ByMiracor Medical SA

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