Remove Innovation Remove Stents Remove Technology
article thumbnail

Philips launches Duo Venous Stent System for Treatment of Symptomatic Venous Outflow Obstruction

DAIC

and an investigator in the VIVID study , which contributed to the device’s FDA approval – successfully used the Duo Venous Stent System for the first time outside of a clinical trial. Duo Hybrid has a distinct integrated design that combines multiple zones of differing mechanical properties into a single stent [3].

Stent 105
article thumbnail

Getinge Enters into Commercial Distribution Agreement with Cook Medical for iCast Covered Stent System in the United States

DAIC

milla1cf Wed, 04/17/2024 - 16:18 April 17, 2024 — Getinge and Cook Medical announced an exclusive sales and distribution agreement for the iCast covered stent system, which has been on the market for twenty years and recently received premarket approval for treatment of iliac arterial occlusive disease.

Stent 105
article thumbnail

Abbott Enters IVL Burgeoning Segment

CardiacWire

With the FDA nod, Abbott can now evaluate the IVL system in treating severe calcification in coronary arteries prior to stenting. Abbotts new IVL IDE was two years in the making following its $890M acquisition of Cardiovascular Systems in 2023 that gave the medtech giant an entry into the IVL arena.

Plaque 59
article thumbnail

SMT and HeartX Forge Transformative Partnership in Cardiovascular Space

DAIC

milla1cf Mon, 05/06/2024 - 10:55 May 6, 2024 — SMT (Sahajanand Medical Technologies), a leading medical device company at the forefront of innovative patient care in the cardiovascular segment has announced a strategic partnership with HeartX , a pioneering MedTech company focused on research and development.

article thumbnail

Elixir Medical Granted FDA Breakthrough Device Designation for DynamX Bioadaptor

DAIC

The designation recognizes the novelty of the technology and the potential to provide a more effective treatment option for patients with coronary artery disease. 1 To date, interventional treatment of coronary artery disease with drug-eluting stents has been able to establish flow angiographically. Food and Drug Administration (FDA).

article thumbnail

Simpson Interventions Receives FDA Breakthrough Device Designation for Acolyte Image Guided Crossing and Re-Entry Catheter System

DAIC

a pioneering medical technology company specializing in cardiovascular interventional devices, today announced that its groundbreaking Acolyte Image Guided Crossing and Re-Entry Catheter System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration ( FDA ).

article thumbnail

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

DAIC

1 To qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. CLTI is associated with high rates of amputation and mortality as well as high care costs.1