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First coronary drug-coated balloon in U.S. provides safe, effective alternative to treat coronary in-stent restenosis and reduce risk of reoccurrence
News | Drug-Eluting Balloons
Boston Scientific Receives FDA Approval for the AGENT Drug-Coated Balloon

March 1, 2024 — Boston Scientific Corporation today announced it has received U.S. Food and Drug Administration (FDA) ...

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Data from first coronary DCB study in U.S. meet 12-month primary endpoint, demonstrate low adverse event rates with AGENT DCB
News | Drug-Eluting Balloons
Boston Scientific AGENT Drug-Coated Balloon Demonstrates Superiority to Uncoated Balloon Angioplasty in the AGENT IDE Trial

October 30, 2023 — Boston Scientific Corporation on Friday announced positive 12-month results from the pivotal AGENT ...

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First dedicated registry to investigate DCB performance in isolated popliteal artery lesions shows Passeo-18 Lux DCB as beneficial treatment for challenging anatomical segment
News | Drug-Eluting Balloons
BIOLUX P-III BENELUX All-Comers Registry Demonstrates Safety and Efficacy of BIOTRONIK’s Drug-Coated Balloon in Isolated Popliteal Lesions at 24 Months

September 14, 2023 — BIOTRONIK announced the two-year-results from the BIOLUX P-III BENELUX all-comers registry ...

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The first patient has been enrolled in a UK study of large vessel de novo coronary artery disease treated with SELUTION SLR
News | Drug-Eluting Balloons
MedAlliance Announces Enrollment of First Patient in SELUTION SLR LOVE-DEB Coronary Study

September 11, 2023 — The first patient has been enrolled in a UK study of large vessel de novo coronary artery disease ...

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No statistical difference observed across sub-analyses for diabetes, lesion length, calcium, bailout stenting and occlusions in head-to-head study comparing Passeo-18 Lux DCB to In.Pact Admiral DCB
News | Drug-Eluting Balloons
BIOPACT RCT Subgroup Analyses Show Consistently Great Results for Passeo-18 Lux Drug-Coated Balloon

July 14, 2023 — BIOTRONIK announced the one-year subgroup results from the investigator-initiated BIOPACT randomized ...

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The objective of this study was to assess the safety and efficacy of SELUTION SLR, MedAlliance’s novel sirolimus-eluting balloon, for endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and popliteal artery (PA).
News | Drug-Eluting Balloons
Excellent 12-Month Results from SELUTION SFA Trial Presented at JET

May 30, 2023 — Twelve-month results from the SELUTION SFA trial have been presented for the first time at the Japan ...

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MagicTouch PTA -Sirolimus Coated Balloon has recently received IDE approval from the US FDA for SFA indication
News | Drug-Eluting Balloons
Concept Medical’s fourth IDE approval for the MagicTouch Sirolimus Coated Balloon is granted for the treatment of Superficial Femoral Artery Disease (SFA)

May 30, 2023 — The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for ...

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Along with this latest IDE approval for the treatment of Small Vessel indication, Concept Medical received two other IDE approvals for the Magic Touch SCB family of products for the treatment of coronary In-Stent Restenosis (ISR) indication and Below-the-Knee indication (PTA)
News | Drug-Eluting Balloons
Concept Medical's Receives FDA Approval for the MagicTouch-Sirolimus Coated Balloon

May 12, 2023 — The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc’s novel ...

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This study evaluates SELUTION SLR in the treatment of occlusive disease of the superficial femoral artery (SFA) and proximal popliteal artery (PPA) and has been designed to support FDA approval
News | Drug-Eluting Balloons
MedAlliance Enrolls First US Patient into its Third FDA IDE Study: SFA SELUTION4SFA

May 4, 2023 — The first US patient has been enrolled in the SELUTION4SFA Sirolimus DEB study by Dr. Arthur Lee at the ...

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The results of a long-term analysis show necessary adjustments in international guidelines as well as in diagnosis and treatment
News | Drug-Eluting Balloons
IN.PACT AV DCB Sub-analysis Data Shows Sustained Benefit Through 36 Months

April 28, 2023 — Medtronic today shared additional 36-month data from the IN.PACT AV Access Study, as well as 48-month ...

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