DES With Durable Polymers Are Noninferior to Biodegradable DES in HOST-REDUCE-POLYTECH-ACS Trial
October 17, 2020—An investigator-initiated randomized clinical trial (RCT) found that drug-eluting stents (DES) with durable polymers are noninferior to DES with biodegradable polymers in patients with acute coronary syndrome (ACS).
Shorter DAPT Regimen With Abbott's Xience V DES Is Noninferior to Standard DAPT for Ischemic Events
October 15, 2020—Results from the XIENCE 90/28 clinical trials presented by Roxana Mehran, MD, at TCT Connect have shown that a shorter course of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) was noninferior to standard DAPT up to 12 months.
FDA Approves Expanded Indication for Medtronic’s Resolute Onyx DES for 1-Month DAPT in High-Bleeding-Risk Patients
October 1, 2020—Medtronic announced it has received FDA approval for new 1-month dual antiplatelet therapy (DAPT) labeling with an expanded indication for patients at high bleeding risk (HBR) implanted with the company’s Resolute Onyx drug-eluting stent (DES) in the United States.
Ten-Year Safety and Efficacy Data Published for Translumina's Vivo Isar Polymer-Free DES
August 14, 2020—Translumina announced that 10-year follow-up safety and efficacy data from the ISAR TEST-5 study of the company’s Vivo Isar dual-drug polymer-free drug-eluting stent (DES) were published by Professor Sebastian Kufner, MD, et al in Journal of the American College of Cardiology (2020;76:146-158).
One-Year Follow-Up Completed in PIONEER-III Trial of Sinomed’s Buma Supreme DES
July 13, 2020—Sino Medical Science Technology Inc. (Sinomed), a Tianjin, China–based developer of neuro- and cardiovascular technologies, announced the completion of 1-year follow-up in the randomized global PIONEER-III trial evaluating the Buma Supreme coronary drug-eluting stent (DES).
CE Mark Approved for 1-Month DAPT Indication for High Bleeding Risk Patients Treated With Medtronic’s Resolute Onyx DES
June 5, 2020—Medtronic announced it has received European CE Mark approval for a 1-month dual antiplatelet therapy (DAPT) indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx drug-eluting stent (DES).
Analysis of LEADERS FREE Supports Similar PCI Treatment in Women as in Men With High Bleeding Risk
May 29, 2020—The American College of Cardiology announced a recently published study that demonstrated that women with high bleeding risk should not be denied the benefits of percutaneous coronary intervention (PCI) when indicated and that bleeding avoidance strategies should be uniformly adopted for all patients, especially in women.
MedAlliance Gains CE Mark Approval for Coronary Selution SLR Sirolimus-Eluting Balloon
May 14, 2020—MedAlliance SA announced European CE Mark approval for the Selution SLR 014, a sirolimus drug-eluting balloon (DEB) with sustained limus-release (SLR) for the percutaneous transluminal coronary angioplasty to treat of coronary artery disease.
TWILIGHT Substudy Compares Safety of Bioabsorbable Polymer and Durable Polymer DES in High-Risk Patients Undergoing PCI
May 14, 2020—The Society for Cardiovascular Angiography and Interventions (SCAI) announced that subgroup findings from the TWILIGHT trial sought to reveal whether drug-eluting stents (DESs) coated with a bioabsorbable polymer (BP) provided a safety advantage without compromising efficacy compared with durable polymer (DP) formulations.
Pooled Analysis Shows Substantial Long-Term MACE Risk After PCI for Stable Ischemic Heart Disease
April 13, 2020—In Circulation: Cardiovascular Interventions, Mahesh V. Madhavan, MD, et al published findings from an individual patient-level pooled analysis of 19 randomized coronary stent trials evaluating long-term outcomes after revascularization for stable ischemic heart disease.
PRECOMBAT Compares Stenting and CABG Events at 10 Years
March 30, 2020—The American College of Cardiology (ACC) announced that a study with the longest follow-up to date of patients with a high-risk of left main coronary artery disease (LMCAD) showed no significant differences in rates of death, heart attack, or stroke between patients who were treated with a stent and those who underwent coronary artery bypass graft (CABG) surgery.
Medtronic Reports Results From Onyx ONE Clear Study of 1-Month DAPT in High Bleeding-Risk DES Patients
March 30, 2020—Medtronic announced positive results of the Onyx ONE Clear study that evaluated the company's Resolute Onyx drug-eluting stent (DES) in high bleeding-risk (HBR) patients with 1-month dual antiplatelet therapy (DAPT).
Study Shows Similar 1-Year Outcomes for Women and Men Treated With OrbusNeich's Combo DES
March 21, 2020—Online in Catheterization and Cardiovascular Interventions, Jaya Chandrasekhar, MBBS, et al published findings from an examination of sex differences in 1‐year outcomes with the Combo drug-eluting stent (OrbusNeich).
Meta-Analysis Compares DES and CABG for Left Main Coronary Artery Disease
March 2, 2020—Findings from a meta-analysis comparing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) versus coronary artery bypass grafting (CABG) for patients with left main coronary artery disease (LMCAD) were published by Yousif Ahmad, MD, et al online ahead of print in European Heart Journal (EHJ).
US Device Guide
This Device Guides offers a searchable, comprehensive listing of the available interventional cardiology devices in the United States.
European Device Guide
This Device Guides offers a searchable, comprehensive listing of the available interventional cardiology devices in Europe.