Technology | June 15, 2012

Cardiosolutions Receives FDA 510(k) Clearance for Dexterity Steerable Introducer

June 15, 2012 — Cardiosolutions Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Dexterity Steerable Introducer, a next-generation structural heart access introducer and delivery conduit. The Dexterity Steerable Introducer is designed to provide physicians straightforward and uncomplicated access to the heart anatomy by simplifying the cardiac transseptal procedure and facilitating passage of therapies into the entire left atrium, left ventricle and associated heart structures. It is intended to be used for the advancement and delivery of various cardiovascular catheters into the heart, including the left side of the cardiac anatomy through the interatrial septum.

"The Dexterity Steerable Introducer is an exciting, versatile product that permits unparalleled access to the heart chambers. We believe it is an ideal and essential tool for the interventional or electrophysiology (EP) physician who needs precise catheter placement with combined ease of use," said Thomas Piemonte, chief medical officer for Cardiosolutions and director of Interventional Cardiovascular Medicine and Cardiac Catheterization Laboratory at the Lahey Clinic in Burlington, Mass.

Transcatheter therapy of structural heart disease is advancing rapidly. Due to the less invasive approach, transcatheter techniques have replaced surgery as standard procedure for a number of complicated interventional procedures. Evolving interventional techniques allow treatment of rhythm disorders, paravalvular leaks, ventricular septal defects and valve replacement. Until recently, therapy for these diseases was limited to patients in whom severe comorbidities lead to contraindications to surgery.

For more information: www.cardiosolutionsinc.com

Related Content

The SERF VT EFS is a groundbreaking, single-arm observational study designed to evaluate the safety and effectiveness of the Thermedical Durablate catheter to treat VT. #HRS20 #HRS2020 #heartrhythm2020
News | Ablation Systems | May 08, 2020
May 8, 2020 – Results from a first-in-human early feasibility study (EFS) using a saline enhanced radiofrequency (SER
The Affera Inc. pulsed field (PF) energy radiofrequency ablation system. First-in-human trial shows new point-by-point approach provides increased flexibility and efficiency for physicians treating arrhythmia patients. #HRS #HRS2020 #HRS20 #heartrhythm20

The Affera Inc. pulsed field (PF) energy radiofrequency ablation system.

Feature | Ablation Systems | May 08, 2020
May 8, 2020 — A new clinical trial effectively uses pulsed field (PF) energy to treat patients with persistent or par
Noninvasive Radioablation Offers Long-term Benefits to High-risk Heart Arrhythmia Patients
News | Ablation Systems | September 17, 2019
September 17, 2019 — Treating high-risk heart patients with a single, high dose of radiation therapy can dramatically
Biosense Webster Announces Initial Results From First-in-Human QDOT-FAST Study
News | Ablation Systems | May 16, 2019
Johnson & Johnson Medical Devices Companies announced that Biosense Webster, Inc.’s QDot Micro catheter...
CardioFocus Announces Results From HeartLight X3 Ablation System Pivotal Study
News | Ablation Systems | May 16, 2019
CardioFocus Inc. announced the presentation of results from its pivotal confirmatory study evaluating the HeartLight X3...
New Global Consensus Statement Addresses Catheter Ablation of Ventricular Arrhythmias
News | Ablation Systems | May 14, 2019
The Heart Rhythm Society (HRS) in partnership with three other professional societies issued an international consensus...
Netherlands Hospital to Install State-of-the-Art MRI Ablation Center
News | Ablation Systems | May 13, 2019
Imricor announced the signing of a commercial agreement with the Haga Hospital in The Hague, Netherlands to outfit a...
A CyberHeart cardiac ablation radiotherapy treatment plan showing where the radiation beam will ablate for a noninvasive pulmonary vein isolation procedure. Varian acquires, buys, purchases Cyberheart.

A CyberHeart cardiac ablation radiotherapy treatment plan showing where the radiation beams will ablate for a noninvasive pulmonary vein isolation procedure to treat an arrhythmia.

Feature | Ablation Systems | May 10, 2019 | Dave Fornell, Editor
May 10, 2019 — Radiation oncology vendor Varian announced it acquired the start-up company CyberHeart, which has deve