News

Treatment options for high-risk heart patients with severely calcified coronary artery disease (CAD) have been limited for more than 20 years. Now, Robert Wood Johnson University Hospital (RWJUH)...

The U.S. Food and Drug Administration (FDA) cleared Cardiovascular Systems Inc.’s Diamondback 360 60 cm Peripheral Orbital Atherectomy Systems (OAS) for the treatment of peripheral arterial...

Spectranetics Excite ISR Atherectomy Systems Cath Lab Clinical Trial Study

The Spectranetics Corp. announced that the Excite ISR trial achieved the statistical endpoints of the adjunct analysis...

AngioDynamics AngioVac Atherectomy Systems Cath Lab Thrombectomy Devices

Instead of making a chest incision for open heart surgery, cardiovascular surgeons can now use a new vacuum-like tool to remove potentially deadly, large clots that lodge in patients’ hearts....

AtheroMed Phoenix Atherectomy System Device Peripheral Artery Disease PAD

AtheroMed, a developer of catheter technologies for treating ...

The Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) 2013 offers many new insights about the latest cardiovascular technologies and treatment techniques. These...

diamondback 360 mount sinai cath lab atherectomy

Interventional cardiologists at Mount Sinai Hospital are the first in the world to use a newly U.S. Food and Drug Administration (FDA)-approved device for the treatment of severely calcified...

atherectomy systems cath lab diamondback 360 OAS

The U.S. Food and Drug Administration (FDA) approved Cardiovascular Systems Inc.’s Diamondback 360 Coronary Orbital ...

atherectomy cath lab fda diamondback 360 coronary orbital system CSI

Cardiovascular Systems Inc. (CSI) announced that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360 Coronary Orbital ...

October 22, 2013 — AtheroMed, a developer of catheter technologies for treating peripheral artery disease (PAD),...

stents peripheral atherectomy devices artery disease PAD covidien everflex

Covidien released positive final results from its Durability II study and promising preliminary data from its Definitive AR trial at the Vascular Interventional Advances (VIVA) 2013 conference in...

Avinger Inc. has received CE Mark approval for Pantheris – a system that combines directional atherectomy capabilities with real-time intravascular visualization to remove plaque from blocked...

Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has cleared two new Jetstream atherectomy catheters. The SC (Single Cutter) atherectomy catheter is available in 1....

Cardiovascular Systems Inc. orbital atherectomy system LIBERTY 360°clinical tria

Cardiovascular Systems Inc. (CSI) announced that the first patient has been enrolled in its post-market clinical study...

Cardiovascular Systems Inc. (CSI) has presented 30-day results from its ORBIT II study of coronary artery disease. ORBIT II is evaluating the safety and effectiveness of the company’s orbital...

March 7, 2013 — Cardiovascular Systems Inc. (CSI) presented three-year data from its ORBIT I feasibility study of calcified coronary lesions during a poster session at the 2013 Cardiovascular...

January 31, 2013 — Cardiovascular Systems Inc. (CSI) announced CONFIRM study series data presented at the 2013 International Symposium on Endovascular Therapy (ISET).

Spectranetics Peripheral Artery Disease Laser Atherectomy

The Spectranetics Corporation announced final results from the PATENT (Photo-Ablation using the TURBO-Booster(R) and Excimer Laser for In-Stent Restenosis Treatment) study evaluating the safety...

Covidien DEFINITIVE LE Study Peripheral Artery Disease SilverHawk TurboHawk

Covidien announced the completion of enrollment in its DEFINITIVE AR (anti-restenosis) study. As the third study in the DEFINITIVE trial series, this randomized pilot is designed to address the...

Covidien DEFINITIVE LE Study Peripheral Artery Disease

Covidien announced final 12-month results from its DEFINITIVE LE (Determination of Effectiveness of SilverHawk/TurboHawk Peripheral Plaque Excision Systems for the Treatment of Infrainguinal...

June 22, 2012 — Bayer HealthCare widens its portfolio of interventional solutions by introducing the Jetstream Navitus L Atherectomy Catheter. Positioned as the largest diameter rotational...

November 15, 2011 — A new clinical trial is testing the efficacy of rotational atherectomy (or rotablation, a process of drilling through plaque deposits) prior to implantation of a drug-eluting...

October 17, 2011 — The Detroit Medical Center (DMC) Cardiovascular Institute (CVI) has become the first cardiac care facility in Michigan to successfully open a patient's blocked artery with a...

September 1, 2011 ­– Medrad Inc. has acquired Pathway Medical Technologies Inc. to strength its vascular interventional business by expanding its offers with Pathway’s mechanical atherectomy...

May 5, 2011 – Volcano Corp. announced a supply agreement with ev3, a Covidien company, under which Volcano will supply its intravascular ultrasound (IVUS) technology for use in ev3's Plaque Excision...

November 5, 2010 – Cardiovascular Systems Inc. (CSI) will pay $1 million to settle an employment lawsuit with ev3, which is now part of Covidien.

The litigation stems from a lawsuit ev3...

September 7, 2010 – Enrollment started in the Endovascular Atherectomy Safety and Effectiveness (EASE) study to evaluate the safety and effectiveness of the Phoenix Atherectomy catheter. The...

August 4, 2010 — A second-generation of the Diamondback Predator 360 peripheral arterial disease (PAD) system features improvements in the crowns and shaft for enhanced clinical performance and...

June 22, 2010 – The U.S. Food and Drug Administration (FDA) recently granted 510(k) clearance for the Jetstream G3 Small Fixed (SF) peripheral atherectomy catheter. It is smaller than previous...

June 11, 2010 – A multicenter, randomized trial planned in the United States will compare laser ablation followed by adjunctive balloon angioplasty as compared to balloon angioplasty alone in...

June 2, 2010 – Covidien announced yesterday it is purchasing ev3 Inc. for $2.6 billion to expand its percutaneous vascular portfolio. The company hopes to become a leading endovascular player in...

May 27, 2010 – The first patient was recently enrolled in the ORBIT II investigational device exemption (IDE) clinical trial to evaluate the safety and effectiveness of its Diamondback 360...

April 28. 2010 – A trial examining the use of an orbital atherectomy device on calcified coronary lesions was granted U.S. Food and Drug Administration (FDA) unconditional approval this week.

March 12, 2010 – A rotational thrombectomy system has been indicated for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts.

Argon...

January 15, 2010 – The FDA has approved a trial to evaluate the safety and effectiveness of the Diamondback 360º atherectomy system in treating calcified coronary lesions.

January 13, 2010 – A study evaluating the effectiveness of the Clir-Path laser atherectomy system met its primary endpoint by reducing the diameter of stenosis. Results from the CELLO (CLiRpath...

December 30, 3009 – The U.S. Justice Department said yesterday Spectranetics Corp. agreed to pay $4.9 million in civil damages, plus a $100,000 forfeiture, to resolve allegations it illegally...

December 15, 2009 – CE Mark approval has been granted for Pathway Medical Technologies’ Jetstream G2TM NXT System, a peripheral atherectomy catheter for use in the treatment of PAD.

October 1, 2009 – Spectranetics Corp. yesterday said it filed a 510(k) application with the U.S. Food and Drug Administration seeking clearance for the treatment of in-stent restenosis (ISR) in...

September 21, 2009 — Minnow Medical recently announced it will be presenting interim clinical data regarding a novel technology to treat Peripheral Artery Disease (PAD) on Monday, Sept. 21. The...

August 11, 2009 – Pathway Medical Technologies Inc. today introduced the 7 French compatible version of its peripheral atherectomy catheter, the Jetstream G2 NXT.

July 10, 2009 – Spectranetics Corp. said today it received FDA-clearance to market the Turbo-Tandem, a single-use, disposable device indicated for atherectomy of infrainguinal arteries.

CE...

July 2, 2009 – Researchers from Dartmouth-Hitchock Medical Center (DHMC) in Lebanon, N.H., have published a new study in the July issue of the Journal of Vascular Surgery (published by the Society...

May 6, 2009 - Spectranetics Corp. yesterday said it made a pre-IDE (investigational device exemption) submission to the FDA regarding the use of laser ablation to treat in-stent restenosis (ISR)...

April 16, 2009 - Minnow Medical this week received the CE mark, clearing its disposable Guided Reshaping Technology (GRT) catheter to treat peripheral artery disease (PAD) for marketing in the...

February 3, 2009 - The FDA has granted Pathway Medical Technologies Inc., 510(k) clearance to market its newest peripheral atherectomy catheter, the Jetstream G2, for use in the treatment of...

September 5, 2008 - Pathway Medical Technologies Inc., today received FDA clearance to market Jetstream, a peripheral atherectomy catheter designed for use in the treatment of peripheral artery...

November 28, 2007 - Recent statistical updates are published in the December 2007 issue of the Journal of Vascular Surgery that compare carotid endarterectomy (CEA), lower extremity bypass (LEB)...

October 24, 2007 – ev3 Inc. highlighted at TCT 2007 its merger with FoxHollow Technologies, Inc., which created an organization that possesses one of the largest U.S. distribution footprints in...

July 5, 2007 – The FDA has cleared Spectranetics Corp. to market its TURBO-Booster product for the treatment of arterial stenoses and occlusions in the leg, a peripheral laser catheter that...

April 20, 2007 — The U.S. interventional cardiology market value increased 1.5 percent in Q1 2007 over Q4 2006, according to Millennium Research Group's (MRG) Marketrack service.