March 9, 2022 — Medtronic is recalling (correcting) the TurboHawk Plus Directional Atherectomy System due to design similarities shared with another device that was recently recalled for correction ...
Atherectomy Devices
This channel includes news and new technology innovations for atherectomy systems used in peripheral or coronary arteries to debulk lesions and vessel preparation prior to angioiplasty or stenting.
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February 17, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Shockwave Medical's Intravascular Lithotripsy (IVL) system to treat severely calcified coronary artery disease. The ...
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November 7, 2019 — There was no difference between drug-coated balloons (DCB) vs. plain old balloon angioplasty (POBA) following B-Laser atherectomy, according to late-breaking study results from the ...
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Henry Ford Hospital in Detroit gets a lot of referrals for very sick patients seeking a last resort treatment in its high-risk percutaneous coronary intervention program (CHIP). Many of these are ...
March 9, 2022 — Medtronic is recalling (correcting) the TurboHawk Plus Directional Atherectomy System due to design ...
March 09, 2022
January, 24, 2022 — Medtronic Inc. is recalling its HawkOne Directional Atherectomy System product due to the risk of ...
January 24, 2022
January 10, 2022 — Cardiovascular Systems Inc. (CSI) is recalling the Wirion atherectomy embolic protection device ...
January 10, 2022
November 10, 2021 — Philips Healthcare announced North American availability of new innovations in its portfolio of ...
November 10, 2021
February 17, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Shockwave Medical's Intravascular ...
February 17, 2021
September 14, 2020 — Avinger received U.S. Food and Drug Administration (FDA) 510(k) clearance from the FDA for its ...
September 14, 2020
July 20, 2020 – BD (Becton, Dickinson and Company) recently completed the acquisition of Straub Medical AG, a privately ...
July 20, 2020
February 13, 2020 — The U.S. Food and Drug Administration (FDA) has issued its final guidance on "Peripheral Vascular ...
February 13, 2020
November 7, 2019 — The REVEAL FDA investigational device exemption (IDE) trial confirmed a favorable safety and ...
November 11, 2019
November 7, 2019 — There was no difference between drug-coated balloons (DCB) vs. plain old balloon angioplasty (POBA) ...
November 07, 2019
October 21, 2019 — Cardiovascular Systems Inc. recently announced U.S. Food and Drug Administration (FDA) premarket ...
October 21, 2019
Henry Ford Hospital in Detroit gets a lot of referrals for very sick patients seeking a last resort treatment in its ...
October 08, 2019
September 13, 2019 — Rex Medical L.P. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for ...
September 13, 2019
August 6, 2019 — Cardiovascular Systems Inc. (CSI) has acquired the Wirion Embolic Protection System and related assets ...
August 06, 2019
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