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Cordis Cypher's Long-Term Safety and Efficacy Supported by 4-Year TYPHOON Data

January 19, 2011—Christian Spaulding, MD, et al published 4-year follow-up data from the TYPHOON (Trial to Assess the Use of the Cypher Sirolimus-Eluting Coronary Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty) study in the Journal of the American College of Cardiology: Cardiovascular Interventions (2011;4:14–13).

Enrollment Begins for Stentys’ APPOSITION II

December 4, 2009—Stentys, Inc. (Princeton, NJ) announced the commencement of enrollment in the APPOSITION II clinical study, which is a randomized trial comparing the Stentys self-expanding stent with a conventional balloon-expandable stent in acute myocardial infarction (AMI) patients.

SoniVie’s Tivus Renal Denervation System Receives IDE Approval for the REDUCED1 Pilot Study

June 20, 2022—SoniVie Ltd., an Israel-based company developing the Tivus therapeutic intravascular ultrasound system to treat a variety of hypertensive disorders, announced that the FDA granted investigational device exemption (IDE) approval for the REDUCED1 pilot study, which will evaluate the Tivus ultrasound ablation system for renal denervation (RDN) in the treatment of patients with resistant hypertension.

MedAlliance’s Large-Scale SELUTION DeNovo Study Enrollment Reaches Halfway Point

September 14, 2023—MedAlliance announced an update of patient enrollment in the SELUTION DeNovo coronary randomized study, which is comparing a treatment strategy using the company’s Selution SLR sirolimus drug-eluting balloon versus any limus drug-eluting stent (DES).

Cardiawave’s Valvosoft Approved in Europe for Treatment for Severe Symptomatic Aortic Stenosis

December 4, 2025—Cardiawave announced it has received CE Mark approval for Valvosoft noninvasive ultrasound therapy (NIUT) device for the treatment of severe symptomatic aortic stenosis (sSAS).

SoniVie’s REDUCED-1 Pilot Study of Tivus Ultrasound RDN System Completes Enrollment

February 1, 2024—SoniVie announced that the final patient was treated in the REDUCED-1 pilot study of the company’s Tivus renal artery denervation technology to treat resistant hypertension.

SELUTION DeNovo Trial Substudy Compares SEB and DES in NSTEMI Patients

April 23, 2026—A substudy from the SELUTION DeNovo study analyzed 1,089 patients with non–ST-segment myocardial infarction (NSTEMI) or unstable angina to assess 1-year heart-related problems after treatment with either a drug-eluting stent (DES) or the Selution SLR sirolimus-eluting balloon (SEB; Cordis) with provisional stenting.

MedAlliance’s SELUTION DeNovo Study Reaches Enrollment Milestone

March 14, 2023—MedAlliance announced an update on the progress of enrollment in its SELUTION DeNovo coronary randomized study, which commenced in 2021.

Cardiawave’s Valvosoft Pivotal Study 6-Month Follow-Up Data Presented

November 11, 2024—Cardiawave SA, developer of the Valvosoft noninvasive ultrasound therapy (NIUT) device for the treatment of severe symptomatic calcific aortic stenosis, recently announced that the device met the primary endpoint in its pivotal study and improved or stabilized heart failure symptoms for 80.5% of patients, substantially improving hemodynamics and patient quality of life 6 months after treatment.

SELUTION DeNovo and SELUTION4ISR Studies Evaluate Cordis’ Selution SLR DEB 

October 26, 2025—Results of two studies evaluating the performance of the Selution SLR sirolimus drug-eluting balloon (DEB; Cordis) were presented in a late-breaking clinical trials session at the TCT 2025 scientific symposium.