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.
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 angioplasty or stenting. Atherectomy systems use laser light, spinning blades or drill tips and grinding burrs to cut away the calcified sections of the vessel wall. These systems usually have an integrated aspiration system to remove emboli from the vessel during the procedure. Removal of the calcium allows stents to be fully expanded to prop open vessels with restricted blood flow causing ischemia or a heart attack.
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November 7, 2019 — There was no difference between drug-coated balloons (DCB) vs.
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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).
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Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remain a challenge for even the most experienced operators leading to an increase in...
A comparison showing angiography and optical coherence tomography (OCT) views of an undilated mid right coronary artery calcified lesion, post dilation with the Shockwave intravascular lithotripsy system, and the final result after stenting. The technology allows calcified lesions to be broken up without the need for vessel trauma caused by high pressure balloons or atherectomy.
Feature | Balloon Catheter | February 17, 2021
February 17, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Shockwave Medical's Intravascular...
News | Chronic Total Occlusion (CTO) | September 14, 2020
September 14, 2020 — Avinger received U.S. Food and Drug Administration (FDA) 510(k) clearance from the FDA for its...
The Rotarex S rotational atherectomy system.
News | Atherectomy Devices | July 20, 2020
July 20, 2020 – BD (Becton, Dickinson and Company) recently completed the acquisition of Straub Medical AG, a privately...
A CSI Diamondabck 360 atheretectomy system in use during a cath lab procedure at Henry Ford Hospital in Detroit. Photo by Dave Fornell
News | Atherectomy Devices | February 13, 2020
February 13, 2020 — The U.S. Food and Drug Administration (FDA) has issued its final guidance on "Peripheral Vascular...
The Rex Medical Revolution rotational atherectomy system incorporates continuous aspiration and has a dual indication for atherectomy and thrombectomy.
News | Atherectomy Devices | November 11, 2019
November 7, 2019 — The REVEAL FDA investigational device exemption (IDE) trial confirmed a favorable safety and...
The AngioDynamics/Eximo Medical B-Laser atherectomy system.
News | Atherectomy Devices | November 07, 2019
November 7, 2019 — There was no difference between drug-coated balloons (DCB) vs. plain old balloon angioplasty (POBA)...
Technology | Guidewires | October 21, 2019
October 21, 2019 — Cardiovascular Systems Inc. recently announced U.S. Food and Drug Administration (FDA) premarket...
360 Photos | 360 View Photos | October 08, 2019
Henry Ford Hospital in Detroit gets a lot of referrals for very sick patients seeking a last resort treatment in its...
Technology | Atherectomy Devices | September 13, 2019
September 13, 2019 — Rex Medical L.P. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)...
News | Embolic Protection Devices | August 06, 2019
August 6, 2019 — Cardiovascular Systems Inc. (CSI) has acquired the Wirion Embolic Protection System and related assets...
Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.
Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remain...
News | Atherectomy Devices | July 18, 2018
July 18, 2018 — Avinger Inc. announced in June that several physicians have successfully treated over 40 patients for...
Technology | Atherectomy Devices | May 24, 2018
May 24, 2018 — Avinger Inc. announced that the company received 510(k) clearance from the U.S. Food & Drug...
News | Ablation Systems | April 04, 2018
April 4, 2018 — Boston Scientific Corp. announced the acquisition of Securus Medical Group Inc., a privately-held...
Technology | Atherectomy Devices | January 16, 2018
January 16, 2018 — Medtronic plc announced the company’s Neurovascular business unit received U.S. Food and Drug...
