DES Center

iVascular’s ANGIODAPT Trial Completes Enrollment

February 2, 2026—iVascular announced the completion of patient recruitment for the ANGIODAPT trial, which is evaluating ischemic and bleeding outcomes after implantation of the iVascular Angiolite drug-eluting stent and abbreviated dual antiplatelet therapy (DAPT).

Orchestra BioMed’s Pivotal Trial of Virtue SAB for Coronary ISR Begins Enrollment

November 10, 2025—Orchestra BioMed Holdings, Inc. announced that the first patients were enrolled in the United States investigational device exemption (IDE) pivotal study for the company’s Virtue sirolimus angioinfusion balloon (Virtue SAB) in the treatment of coronary in-stent restenosis (ISR).

TUXEDO-2 Evaluates PCI With Ultrathin Stents in Diabetic Patients With Multivessel Disease

November 10, 2025—Percutaneous coronary intervention (PCI) using contemporary drug-eluting stents (DESs) demonstrated favorable safety and efficacy outcomes in diabetic patients with multivessel disease (MVD), according to results of the TUXEDO-2 trial.

Reflow’s Pilot Study of Spur Elute Scaffold for ISR Completes Enrollment

September 29, 2025—Reflow Medical, Inc. announced the completion of enrollment in DEEPER CORONARY, a pilot study evaluating the company’s Spur Elute coronary sirolimus-eluting retrievable scaffold system as a primary treatment for in-stent restenosis (ISR) of the coronary arteries.

DUBSTENT DIABETES Trial of Combined PCI Approach Enrolls First Patient 

September 16, 2025—Teleflex Incorporated announced the enrollment of the first patient in the DUBSTENT DIABETES trial that will evaluate a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus.

Elixir Medical’s DynamX Studied at 3 Years in BIOADAPTOR RCT

May 30, 2025—Elixir Medical recently announced 3-year results from the BIOADAPTOR randomized controlled trial (RCT) comparing the company’s DynamX coronary sirolimus-eluting bioadaptor system to the standard-of-care Resolute Onyx zotarolimus drug-eluting stent (DES; Medtronic).

Medtronic’s Prevail DCB Evaluated in SCAAR Analysis

March 12, 2025—Medtronic recently announced results from an analysis of the company’s Prevail paclitaxel drug-coated balloon (DCB) catheter in the SCAAR registry.

Teleflex to Acquire Biotronik’s Vascular Intervention Business

February 27, 2025—Teleflex Incorporated announced it has entered into a definitive agreement to acquire substantially all of the Vascular Intervention business of Biotronik.

AHA Scientific Statement Provides Expert Update on Critical Care Cardiology and CICUs

February 24, 2025—The American Heart Association (AHA) recently announced the publication of a new scientific statement that provides an update and contemporary expert perspective on the organizational structure, staffing, and care delivery in the cardiac intensive care unit (CICU) in the evolving discipline of critical care cardiology.

iVascular Angiolite DES Evaluated at 5 Years in RANGO Registry

February 20, 2025—iVascular announced 5-year results from the RANGO registry evaluating the long-term safety and efficacy of the company’s Angiolite sirolimus drug-eluting stent (DES) in unselected patients in real-world practice.

Biotronik’s Orsiro Mission DES Approved for New Indications in Europe

January 14, 2025—Biotronik announced the approval of two new indications for the Orsiro Mission drug-eluting stent (DES): (1) 1-month dual antiplatelet therapy (DAPT) for high-bleeding-risk patients and (2) treatment of calcified lesions.

SMT Supraflex Cruz DES for HBR Patients Evaluated in COMPARE RCT

October 16, 2024—Sahajanand Medical Technologies (SMT) announced results of the COMPARE 60/80 HBR trial evaluating the company’s Supraflex Cruz stent in high-bleeding-risk (HBR) patients.

SMT’s Supraflex Cruz DES Approved in Australia

September 27, 2024—Sahajanand Medical Technology Pvt Ltd (SMT), which is based in Mumbai, India, announced that its flagship drug-eluting stent (DES), Supraflex Cruz, has received regulatory approval from the Therapeutic Goods Administration in Australia for the treatment of coronary artery disease.

REC-CAGEFREE I Trial Compares Paclitaxel DCB and Sirolimus DES to Treat De Novo Noncomplex CAD

September 9, 2024—In the first randomized trial to compare clinical outcomes in previously untreated patients with noncomplex disease undergoing percutaneous coronary intervention (PCI), novel drug-coated balloons (DCB) were not superior to standard treatment with second-generation drug-eluting stents (DES), announced the European Society of Cardiology (ESC).

Elixir Medical Reports INFINITY-SWEDEHEART Met 12-Month Primary Endpoint

September 2, 2024—Elixir Medical announced that the INFINITY-SWEDEHEART randomized controlled trial (RCT), which is evaluating the company’s DynamX coronary bioadaptor system with the Resolute Onyx zotarolimus drug-eluting stent (DES), met its 12-month primary endpoint of target lesion failure (TLF) noninferiority (2.35% vs 2.77%; P < .001).  The data were presented as part of a late-breaking session at the European Society of Cardiology Congress in London, England, United Kingdom.

Reflow Medical Commences DEEPER CORONARY Pilot Study of Spur Elute Retrievable Scaffold

July 1, 2024—Reflow Medical, Inc. announced that the first patients were enrolled in DEEPER CORONARY, a pilot study of the company’s Spur Elute sirolimus-eluting retrievable scaffold system as a primary treatment for in-stent restenosis (ISR) of the coronary arteries.

Biotronik’s Orsiro Mission DES With Expanded Maximum-Allowed Diameters Range Is Introduced

July 1, 2024—Biotronik announced the availability of an expanded maximum-allowed diameters (MAD) range for the Orsiro Mission drug-eluting stent (DES).

Elixir’s DynamX Bioadaptor System Granted FDA Breakthrough Device Designation

June 18, 2024—Elixir Medical announced that the company’s DynamX sirolimus-eluting coronary bioadaptor system has been granted Breakthrough Device designation by the FDA.

Elixir Medical’s DESyne BDS Plus RCT 12-Month Data Presented

May 24, 2024—Elixir Medical recently announced 12-month clinical data from the DESyne BDS Plus randomized controlled trial (RCT).

Elixir Medical’s DynamX Bioadaptor Evaluated in 2-Year BIOADAPTOR Data

May 20, 2024—Elixir Medical announced 2-year results from the BIOADAPTOR randomized controlled trial (RCT), which is comparing Elixir’s DynamX sirolimus-eluting coronary bioadaptor system to the standard-of-care Resolute Onyx zotarolimus drug-eluting stent (DES; Medtronic).