Technology | Chronic Total Occlusion (CTO) | January 30, 2019

FDA Clears XableCath Crossing Catheters

New tool for crossing peripheral chronic total occlusions and chronic venous obstructions

FDA Clears XableCath Crossing Catheters

January 30, 2019 — XableCath Inc., announced that its XableCath blunt and abrasion tip catheters were cleared by the U.S. Food and Drug Administration (FDA) as peripheral crossing catheters. The catheters have been safely and successfully used to cross challenging lesions in both arterial chronic total occlusions (CTOs) and chronic obstructive venous lesions. The recent crossing FDA clearance adds to the previous clearances for endovascular support.

Data collected in 11 medical centers in the U.S. and the E.U. have demonstrated a 95 percent success rate in crossing arterial lesions with the devices, and 100 percent success in crossing venous lesions. In more than 70 cases, zero complications have been observed related to XableCath usage.

The company is commencing a selective commercial launch this quarter and will be developing a coronary version of its Crossing Catheter.

For more information: www.xablecath.com

Related Content

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.
Providing Follow-Up Care After Heart Attack Helps Reduce Readmissions, Deaths
News | Cath Lab | April 09, 2019
A program designed to help heart attack patients with the transition from hospital to outpatient care can reduce...
TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy
Technology | Cath Lab | April 08, 2019
TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its...
Cook Medical Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments
News | Cath Lab | March 20, 2019
March 20, 2019 — Cook Medical is recalling one lot of its...
DABRA Excimer Laser System Demonstrates Success in Treating PAD
News | Cath Lab | February 27, 2019
Ra Medical Systems Inc. announced a 98 percent success rate in the results from a 52-patient study using the company’s...
Edwards Lifesciences Recalls Swan-Ganz hemodynamic catheters.
Feature | Cath Lab | February 06, 2019
Edwards Lifesciences is recalling its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufa
Scientists Discover New Heart Attack Repair Pathway

A macrophage immune cell, with a dead cell (pink) that has been eaten, and a mitochondrion (green) between the dead cell and the nucleus. The study’s findings indicate that what the macrophage eats is taken up by the mitochondrion, which in turn communicates with the nucleus to activate the macrophage to promote tissue repair. Image courtesy of Northwestern Medicine.

News | Cath Lab | January 30, 2019
Northwestern Medicine scientists have discovered a novel signaling pathway that promotes healing after a heart attack....
Shockwave Initiates U.S. Pivotal Study for Coronary Intravascular Lithotripsy
News | Cath Lab | January 16, 2019
Shockwave Medical Inc. has initiated its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE...
Overlay Init