Technology | November 07, 2013

FDA Clears Diamondback 360 Coronary Orbital Atherectomy System

atherectomy systems cath lab diamondback 360 OAS
November 7, 2013 — The U.S. Food and Drug Administration (FDA) approved Cardiovascular Systems Inc.’s Diamondback 360 Coronary Orbital Atherectomy System (OAS) for treatment of patients with severely calcified coronary lesions and who are candidates for percutaneous transluminal coronary angioplasty (PTCA) and have previously not been treated.
 
The DiamondBack system consists of a CSI Saline Infusion Pump, ViperWire Advanced Guide Wire, ViperSlide Lubicant and a diamond-coated crown. It is intended to facilitate the delivery of a stent within the narrow coronary artery to improve blood flow.
 
The system should not be used in patients when:  
  • The guide wire cannot pass across the coronary lesion.
  • The target lesion is within a bypass graft or stent.
  • The patient is not an appropriate candidate for bypass surgery, angioplasty or atherectomy therapy.
  • The patient has angiographic evidence of thrombus.
  • The patient has only one open vessel.
  • The patient has angiographic evidence of significant dissection at the treatment site.
  • The patient is a child or pregnant woman.
 
The FDA letter can be viewed here: www.accessdata.fda.gov/cdrh_docs/pdf13/P130005a.pdf
 
For more information: www.csi360.com

Related Content

New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows 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 in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

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 remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Overlay Init