A blog about what is new (and old) in the world of active implantable medical devices 

Facebook Twitter Gplus Flickr LinkedIn YouTube RSS
magnify
Home Therapies Archive for category "Cardioversion/Defibrillation"
formats

TYRX receives FDA Approval for Fully Resorbable AIGISRx R Antibacterial IPG Envelope

AIGISRx® is an Antibacterial Envelope that is made from knitted polypropylene mesh substrate, coated with a polyarylate bioresorbable polymer containing two antimicrobial antibiotics, minocycline and rifampin. AIGISRx is a dual component (resorbable and non-resorbable), sterile prosthesis designed to reduce infection and to stabilize the implantable pacemaker or defibrillator when implanted in the body.

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on TYRX receives FDA Approval for Fully Resorbable AIGISRx R Antibacterial IPG Envelope  comments 
formats

St Jude Receives CE Mark for Quadra Assura MP™ Multipoint CRT-D

St. Jude Medical today announced CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D). The device features MultiPoint™ Pacing (MPP) technology that enables physicians to pace multiple locations on the left side of the heart. This gives the clinician more choices to best optimize cardiac resynchronization therapy (CRT)

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on St Jude Receives CE Mark for Quadra Assura MP™ Multipoint CRT-D  comments 
formats

FDA Approves St. Jude’s Ellipse™ and SJM Assura™ Portfolio of ICDs and CRT-D Devices

St. Jude Medical announced FDA approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new devices are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery. According to the announcement: The Ellipse and SJM Assura family of devices

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on FDA Approves St. Jude’s Ellipse™ and SJM Assura™ Portfolio of ICDs and CRT-D Devices  comments 
formats

Sorin Receives FDA Approval for SMARTVIEW™ Remote Monitoring Solution

Sorin today announced it received FDA approval for and is beginning the U.S. launch of the SMARTVIEW™ remote monitoring solution for patients with CRM devices.  From the press release: “Using the secure SMARTVIEW remote monitoring solution, physicians and nurses following patients with a Sorin PARADYMTM RF device can access valuable cardiac data and alert messages from

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Sorin Receives FDA Approval for SMARTVIEW™ Remote Monitoring Solution  comments 
formats

Biotronik Receives FDA Approval for Ilesto 7 ICD/CRT-D Series

Biotronik announced that FDA granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. According to the press release: “BIOTRONIK lives up to its reputation for excellence in design and manufacturing with the introduction of the Ilesto family, and the new Ilesto DX device. Physicians depend on complete and timely information, and Ilesto

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Biotronik Receives FDA Approval for Ilesto 7 ICD/CRT-D Series  comments 
formats

Medtronic Announces FDA Approval of Next-Generation CRT-D and ICD IPG Families

Medtronic announced today the FDA approval of its new Viva® portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).  According to the press release: “The Viva CRT-D significantly improves response rate to the therapy for many indicated heart failure patients, with a demonstrated 21 percent reduction in overall

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Medtronic Announces FDA Approval of Next-Generation CRT-D and ICD IPG Families  comments 
formats

Sorin Receives Conditional FDA IDE Approval to Study its Paradym CRT-D IPG and SonRtip Hemodynamic Sensor Lead

Sorin announced it received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and clinical trial protocol for RESPOND CRT. The trial will study the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure. RESPOND CRT is a multi-center,

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Sorin Receives Conditional FDA IDE Approval to Study its Paradym CRT-D IPG and SonRtip Hemodynamic Sensor Lead  comments 
formats

Biotronik’s Iforia DF4 ICD/CRT-D CE-Approved as Compatible with MRI

Biotronik announced that it had received CE-approval for the world’s first DF4 ICD/CRT-D series approved for MRI. In addition, this series contains one of the world’s smallest ICDs– the Iforia single chamber ICD. Aside from featuring ProMRI®technology, which allows patients to undergo potentially life saving MRI scans, Iforia also includes the industry standard DF4 connector

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Biotronik’s Iforia DF4 ICD/CRT-D CE-Approved as Compatible with MRI  comments 
formats

Boston Scientific Defibrillators Receive CE Mark for 10-Year Longevity Projections

  Boston Scientific has received CE Mark approval for increased longevity projections for the INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The longevity projections are based on data submitted to the European authorities and vary for each device dependent on the model type and settings. Projected device

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Boston Scientific Defibrillators Receive CE Mark for 10-Year Longevity Projections  comments 
formats

Boston Scientific Receives CE Mark for RELIANCE® 4-FRONT™ Defibrillation Lead

Boston Scientific has received regulatory approval to market the RELIANCE® 4-FRONT™ lead, its next generation implantable defibrillation lead now available in Europe and Asia.   According to the press release, “The RELIANCE 4-FRONT lead is built upon the demonstrated performance and reliability of the RELIANCE lead platform with design enhancements intended to simplify the implant procedure.

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Boston Scientific Receives CE Mark for RELIANCE® 4-FRONT™ Defibrillation Lead  comments 
formats

Boston Scientific Receives FDA Approval of S-ICD® for Patients at Risk of SCA

  On Sept. 28, 2012 Boston Scientific announced that the FDA granted regulatory approval for its S-ICD® System, the world’s first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). The S-ICD System sits entirely just below the skin without the need for leads to be

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Boston Scientific Receives FDA Approval of S-ICD® for Patients at Risk of SCA  comments 
formats

TEDxCambridge Talk Calls for Open Data from AIMDs

In this TED talk, Hugo Campos explains his frustration with the fact that his ICD collects data, but he – as a patient – is unable to access these data as a diagnostic tool to help make good choices about eating, exercise and other activities.

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on TEDxCambridge Talk Calls for Open Data from AIMDs  comments 
formats

FDA Approves St. Jude’s Assura™ ICDs That Reduce Inappropriate Shocks

St. Jude Medical today announced FDA approval of its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).The new implantable defibrillators feature SecureSense™ RV Lead Noise Discrimination, an algorithm that expands the St. Jude Medical ShockGuard® Technology and offers advanced sensing options designed to reduce the incidence of inappropriate shocks for patients

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on FDA Approves St. Jude’s Assura™ ICDs That Reduce Inappropriate Shocks  comments 
formats

St. Jude Seeks Retraction of Heart Rhythm Journal Manuscript by Dr. Robert Hauser Regarding the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads

St. Jude announced it is seeking a retraction of the manuscript accepted for publication in the Heart Rhythm Journal by Dr. Robert Hauser, et al., titled, “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads.” St. Jude claims that the research performed by Hauser undercounted and excluded MAUDE data reports for

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on St. Jude Seeks Retraction of Heart Rhythm Journal Manuscript by Dr. Robert Hauser Regarding the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads  comments 
formats

Boston Scientific to Acquire Cameron Health for $150M Up-Front + $150M Upon FDA Approval

Boston Scientific announced the exercise of its option to acquire Cameron Health.  Cameron Health developed the world’s first and only commercially-available subcutaneous implantable cardioverter defibrillator – the S-ICD® System that I blogged about a few weeks ago. The agreement calls for an upfront payment of $150 million, payable upon transaction closing, an additional potential $150

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Boston Scientific to Acquire Cameron Health for $150M Up-Front + $150M Upon FDA Approval  comments