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Spectranetics’ Stellarex DCB Takes Another Step Toward United States Market Approval With PMA Submission

November 2, 2016 -- The Spectranetics Corporation announced it has submitted the premarket approval (PMA) application to the US Food and Drug Administration for its Stellarex …

Intact Vascular’s TOBA II BTK Pivotal IDE Study Approved by FDA

October 31, 2016 -- Intact Vascular, Inc. announced that the US Food and Drug Administration (FDA) granted staged approval for the company’s investigational device …

Medtronic Receives Clearance for Lower-Profile HawkOne 6-F Directional Atherectomy System

October 24, 2016 -- Medtronic plc announced US Food and Drug Administration 510(k) clearance for its HawkOne directional atherectomy system in a new 6-F size to provide a…

PRISM Assesses Penumbra’s Indigo Aspiration System to Treat Thromboembolism in the Peripheral Vasculature

September 21, 2016 -- Richard R. Saxon, MD, presented data from the PRISM trial during the third Late-Breaking Trials session at VIVA 16, the 14th annual Vascular InterVention…

New Data Presented for Medtronic’s In.Pact Admiral Drug-Coated Balloon

September 19, 2016 -- Medtronic plc announced that 3-year results from the pivotal IN.PACT SFA Trial and 1-year, real-world results from the full clinical cohort of …

Six-Month DISRUPT PAD Results Presented for Shockwave Medical’s Lithoplasty

September 19, 2016 -- Shockwave Medical announced positive clinical results from the pooled DISRUPT PAD study, a single-arm, two-phase, multicenter study evaluating the s…

FDA Approves 6-Month Primary Endpoint for the Lutonix 014 DCB for BTK Treatment

September 19, 2016 -- Bard Peripheral Vascular, Inc. announced that the US Food and Drug Administration (FDA) approved an investigational device exemption supplemental ap…

MOBILE Evaluates Cell Therapy to Treat CLI in Patients With Severe PAD

September 19, 2016 -- Michael P. Murphy, MD, presented the MOBILE study during the first Late-Breaking Trials session at VIVA 16, the 14th annual Vascular InterVentional Advan…

 

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About Endovascular Today

Endovascular Today is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field. Our Editorial Advisory Board is composed of the top endovascular specialists, including interventional cardiologists, interventional radiologists, vascular surgeons, neurologists, and vascular medicine practitioners, and our publication is read by an audience of more than 22,000 members of the endovascular community.