Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Biosense Webster Announces FDA approval of the THERMOCOOL SF Catheter in the United States

January 13, 2012 By AxoGen, Inc.

DIAMOND BAR, Calif.–(BUSINESS WIRE)–Biosense Webster, Inc.,
a worldwide leader in the diagnosis and treatment of cardiac arrhythmias,
announced the FDA approval of the new THERMOCOOL® SF irrigated ablation catheter
in the United States.

The THERMOCOOL® SF NAV Catheter combines Biosense Websters latest
irrigated ablation technology with the accurate visualization of the CARTO®3 3D
Mapping & Ablation System. The catheter was launched in Europe
in October, 2010 and has received excellent feedback from electrophysiologists
who have used the product.

The THERMOCOOL® SF NAV Catheter is approved in the United States
for treatment of drug refractory recurrent symptomatic paroxysmal atrial
fibrillation when used with CARTO® Systems and Type 1 Atrial Flutter for
patients 18 years and older.

Unlike competitive irrigated technologies, the innovative
catheter design and breakthrough porous tip technology with Surround Flow
technology of the THERMOCOOL® SF Catheter allows for uniform cooling of the
entire catheter tip, and efficient heat dissipation when ablating. This cutting
edge innovation provides more effective cooling and allows half the volume load
to the patient, when compared to the traditional THERMOCOOL® Catheter.

“We are proud to offer electrophysiologists in the United States
our latest irrigated ablation technology to help treat patients with cardiac
arrhythmias,” said Shlomi Nachman, Worldwide President, Biosense Webster. “With
the introduction of the THERMOCOOL® SF Catheter, we reinforce our market
leadership in the electrophysiology marketplace and our passion for excellence
in knowledge and innovation.”

About AF and cardiac ablation

Atrial Fibrillation is the most prevalent arrhythmia, and is a leading cause of
stroke among people 65 years and older. Worldwide, it is estimated that 20
million people have AF, yet only ~130,000 are treated with ablation every year.
The public health implications of AF are a growing concern because those with
AF are at an increased risk of morbidity and mortality as well as a reduced
quality of life.

Most patients with AF today are treated with anti-arrhythmic
drugs (AADs), even though about half of them are refractory to these drugs.
During cardiac ablation, energy is delivered through the catheter to those
areas of the heart muscle causing the abnormal heart rhythm. This energy
“disconnects” the pathway of the abnormal rhythm. Cardiac ablation is commonly
used for “simple” arrhythmias, like Wolff-Parkinson-White Syndrome and
atrioventricular nodal re-entry tachycardia (AVNRT), and is increasingly being
used for more complex arrhythmias like ventricular tachycardia and atrial
fibrillation. THERMOCOOL® Navigation Catheters are approved for drug refractory
recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO®
Systems (excluding the NAVISTAR® RMT THERMOCOOL® Catheter).

About Biosense Webster, Inc.

Biosense Webster, Inc., a Johnson & Johnson company, pioneered EP
diagnostic catheters more than 20 years ago and continues to lead the industry
as an innovative provider of advanced cardiac diagnostic, therapeutic, and
mapping tools. As the leader in EP navigation systems and ablation therapy,
Biosense Webster, Inc. has technology that includes the largest installed base
of cardiac mapping navigation systems worldwide in leading hospitals and teaching
institutions. For more information about Biosense Webster and its products,
please visit: www.biosensewebster.com (this site is intended for US
visitors only).

Posted by Sean Fenske, Editor-in-Chief, MDT

Related Articles Read More >

Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Galien Foundation 2022 nominees
18 of the world’s most innovative medical technologies

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech