Remove Coronary Artery Disease Remove Peripheral Arterial Disease Remove Technology
article thumbnail

Elixir Medical Granted FDA Breakthrough Device Designation for DynamX Bioadaptor

DAIC

Elixir Medical has announced the company’s novel bioadaptive implant, DynamX Sirolimus-Eluting Coronary Bioadaptor System, has been granted Breakthrough Device Designation by the U.S. After implantation, the locked phase establishes the maximum flow lumen and restores blood flow to treat symptoms of coronary artery disease (CAD).

article thumbnail

FDA Breakthrough Device Designation for Biotronik Freesolve Below-the-Knee Resorbable Magnesium Scaffold (RMS)

DAIC

CLTI is the most severe form of peripheral arterial disease (PAD), estimated to affect 11% of the 200 million people suffering from PAD globally. degradation of magnesium observed 12 months after implantation in coronary arteries.4 2,3 It has shown 99.6%

article thumbnail

Elixir Medical Receives FDA Breakthrough Device Designation for DynamX BTK System for Below-The-Knee Arterial Disease

DAIC

The company reports this broadens the use of the novel bioadaptor platform technology beyond the treatment of coronary artery disease. The DynamX Bioadaptor platform is a medical technology designed to establish the new standard of care for vascular interventions, according to a written statement on the designation.

article thumbnail

HeartFlow Announces Revolutionary Five-Year Data Demonstrating a 63 Percent Mortality Reduction with FFRCT-Guided Care in PAD Patients

DAIC

1 Atherosclerosis is a systemic disease that affects multiple vascular regions and is particularly severe in PAD patients, where up to 80 percent suffer from concurrent coronary artery disease (CAD), historically linked with a mortality rate exceeding 50 percent within five years. Journal of Vascular Surgery, Mar.

article thumbnail

Johnson and Johnson Completes Acquisition of Shockwave Medical

DAIC

Joaquin Duato , Chairman and Chief Executive Officer of Johnson & Johnson, said, “Through Innovative Medicine and MedTech, Johnson & Johnson is transforming the trajectory of cardiovascular disease, one of the leading causes of death globally.

article thumbnail

Johnson and Johnson to Acquire Shockwave Medical

DAIC

With the addition of Shockwave, Johnson & Johnson will expand its MedTech cardiovascular portfolio into two of the highest-growth, innovation-oriented segments of cardiovascular intervention – coronary artery disease (CAD) and peripheral artery disease (PAD).