News

April 15, 2014 — The Spectranetics Corp. announced U.S. Food and Drug Administration (FDA) clearance of two new mechanical lead extraction platforms that expand physicians' options for the safe...

St. Jude Medical Optisure Defibrillation Lead

St. Jude Medical Inc. announced the global launch of the Optisure defibrillation lead.

Sorin Group has purchased Oscor Inc. lead business, including a lead manufacturing facility in the Dominican Republic for a value of approximately $20 million.

Boston Scientific Ingevity Leads MRI Systems Pacemakers CRT EP Lab

Boston Scientific Corp. received CE marking and launched in Europe the Ingevity family of magnetic resonance imaging...

Biotronik Home Monitoring CRT Leads, Implantable Devices EP Lab

Biotronik announced the first implantations of the Sentus ProMRI lead. Biotronik’s bipolar cardiac resynchronization therapy (CRT) lead is the first MR conditional lead with a 4 French...

FDA Premarket Approval PMA Clinical Study EP Lab Cath Leads Implantable Devices

The U.S. Food and Drug Administration (FDA) has approved many cardiac implantable electronic device...

Boston scientific autogen x4 crt-d crt ICD heart failure cardiac

Boston Scientific Corp. has received CE mark approval of its X4 line of quadripolar ...

Medtronic Inc. announced U.S. Food and Drug Administration (FDA) approval of its Lead Integrity Alert (LIA) software for use with non-Medtronic ...

Data presented at Heart Rhythm 2013 show that Medtronic Inc. Lead Integrity Alert (LIA) software detected pace/sense lead issues in non-Medtronic leads at a greater rate than standard impedance...

The Population Health Research Institute (PHRI) has conducted a further independent analysis of data received from ongoing prospective registries that monitor the performance of the St. Jude...

St. Jude Medical Inc., a global medical device company, has announced first enrollment of its MultiPoint Pacing clinical study to build upon its first- to-market Quadripolar Pacing System....

St. Jude Medical Inc. announced CE Mark approval and European launch of its Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P). This CRT-P system offers more pacing...

 Medtronic Inc. announced market release of the CardioGuide Implant System, a novel real-time navigation system for cardiac resynchronization therapy pacemakers and defibrillators (CRT-P and...

Medtronic Inc. announced it has received CE mark and will begin the European launch of the Attain Performa portfolio of quadripolar leads.

Lumax 740 DX system, ICD

The U.S. Food and Drug Administration (FDA) granted final approval for the Biotronik Lumax 740 DX system. The device is a first-in-class implantable cardiac defibrillator (ICD...

The first patient has been implanted with the Boston Scientific Corporation next generation Ingevity pacing leads in a clinical trial designed to establish the safety, performance and...

December 21, 2012 — Nanostim Inc. announced the first successful implants of a leadless pacemaker in a series of 11 patients at Homolka Hospital in Prague, Czech Republic. The leadless pacemakers...

December 18, 2012 — Zoll Medical Corp. announced that its new U.S. Food and Drug Administration (FDA)-cleared OneStep pediatric CPR electrodes are the only electrodes on the market...

Boston Scientific Corporation Reliance 4-Front Lead

Boston Scientific Corporation has received regulatory approval to market the Reliance 4-Front lead, its...

August 3, 2012 — St. Jude Medical recently announced initial findings from the Riata lead evaluation study. The study’s phase I results found that externalized conductors occurred in 9.3...

Based upon physical examination, St, Jude Medical's analysis indicates the damage to the Durata lead is consistent with external abrasion from contact with a calcified, or hardened, heart valve or...

 

June 21, 2012 — A class action suit has been filed against St. Jude Medical Inc. on behalf of purchasers of the company's defibrillator leads. The Riata and Riata ST...

Boston Scientific Corporation has closed its acquisition of Cameron Health and, as a result, added to its product portfolio the world's first and only commercially available subcutaneous...

Sorin Group at the Heart Rhythm Society (HRS) scientific sessions announced U.S. Food and Drug Administration (FDA) approval and commercial launch for a full portfolio of pacing, defibrillation...

May 11, 2012 — The Sorin Group is launching new implantable devices with a proprietary algorithm system as well as three leads, and releasing data showing improved patient outcomes with a novel...

May 2, 2012 — The Spectranetics Corp. announced U.S. Food and Drug Administration (FDA) approval of the new advanced GlideLight Laser Sheath for removal of cardiac leads.

May 2, 2012 — St. Jude Medical Inc. yesterday released its biannual product performance report (PPR) on its website, updating the performance of all the company’s cardiac rhythm management devices...

April 17, 2012 — St. Jude Medical Inc. announced the first implant in its Accent MRI Pacemaker and Tendril MRI Lead IDE Study. The ultimate goal of the study is to determine if patients...

The gloves are off and the fight has begun between St. Jude Medical and Medtronic over clinical data regarding their ...

April 6, 2012 — St. Jude Medical Inc. announced it has appointed Population Health Research Institute (PHRI), an academic health science research institute, to analyze data from three combined...

April 6, 2012 — St. Jude Medical announced it is proactively informing physicians about visual observations of externalized conductors on the silicone end of QuickSite and QuickFlex left...

March 6, 2012 — Medtronic Inc. announced the launch of the CapSure Sense MRI SureScan pacing leads, which are approved for use during magnetic resonance imaging (MRI), and the receipt of the CE...

St. Jude Medical has launched its Unify Quadra cardiac resynchronization therapy defibrillator (CRT-D) and Quartet left ventricular quadripolar pacing lead. It features four electrodes spaced over...

January 31, 2012 — Medtronic, Inc. announced U.S. Food and Drug Administration (FDA) approval and launch of the DF4 High-Voltage Connector System, a right ventricular lead and connector used with...

December 16, 2011 – St. Jude Medical began a voluntary recall Nov. 28 for its Riata and Riata ST Silicone Defibrillation Leads, which the U.S. Food and Drug Administration (FDA) has now classified...

November 16, 2011 – Cambridge Consultants unveiled how it has collaborated with start-up company EBR Systems to develop the world’s first wireless pacing system.

May 4, 2011 – A new version of the Liberator Locking Stylet uses a distinct radiopaque tip marker to increase radio-opacity under fluoroscopy.

October 15, 2010 – Medtronic has entered into a $268 million settlement relating to its Sprint Fidelis family of defibrillation leads.

June 1, 2010 – A quadripolar pacing system was recently released in Europe and offers physicians the ability to more effectively manage the ever-changing pacing needs of patients with heart...

May 13, 2010 – An integrated, break-away hemostasis valve is integrated into a new lead delivery system is designed to minimize blood loss and allow for easier implantation. The U.S.

May 13, 2010 – A new simulation system to augment traditional procedural training for physicians on laser-assisted lead extraction procedures permits hands-on practice with extraction tools in a...

March 22, 2010 – A pivotal clinical trial recently began to gain U.S. approval for a defibrillator system that does not have any leads in or on the heart. Additionally, no imaging equipment is...

February 3, 2010 – Results of a four-year study evaluating the safety and efficacy of laser assisted lead removal using the Spectranetics laser sheath (SLS II), found a 97.7 percent clinical...

December 8, 2009 – The U.S. Food and Drug Administration (FDA) gave 510(k) clearance last week for Spectranetics’ new VisiSheath Dilator Sheath for pacing and defibrillator lead removal. The...

November 12, 2009 – The first enrollments were made this week in the global Attain Success trial that will evaluate implant success, complication rates and procedure times in the market-released...

June 16, 2009 - Cameron Health Inc. said today it received CE approval for its Cameron Subcutaneous Implantable Defibrillator (S-ICD) system.

June 10, 2009 - St. Jude Medical Inc. today announced the first implant of its Current Plus implantable cardioverter defibrillator (ICD), featuring the SJ4 connector system.

The SJ4...

June 4, 2009 – New research proves the feasibility of leadless pacing in heart failure patients with ultrasound-mediated stimulation energy, which was published in the June edition of the...

May 6, 2009 - Medtronic Inc. today said the FDA approval and availability of the Attain Ability left‐heart lead (Model 4196) for use with cardiac resynchronization therapy (CRT) devices for heart...

May 5, 2009 - Spectranetics Corp. today released initial data from the four-year, retrospective LExICon (Lead Extraction in Contemporary Settings) study demonstrating the safety and efficacy of...

February 6, 2009 – The FDA has approved St. Jude Medical Inc.’s medical device system that allows a single defibrillation lead connection between a cardiac resynchronization therapy defibrillator...

November 18, 2008 - According to a study published in the Nov. 18 issue of the journal Circulation, Medtronic's Lead Integrity Alert (LIA) significantly improves early identification of potential...

August 28, 2008 - Spectranetics Corp. today announced the first use in Japan of its Spectranetics Laser Sheath (SLS II) technology for removal of cardiac leads.

August 26, 2008 - Cook Medical today said 200 medical centers in the U.S. have adopted its EVOLUTION Mechanical Dilator Sheath technology, a new tool designed to remove faulty, ineffective leads...

August 7, 2008 - St. Jude Medical Inc. today said it received regulatory approval, in addition to reimbursement approval, from the Japanese Ministry of Health, Labour and Welfare (MHLW), for the...

July 8, 2008 - Foothills Medical Centre, a leading medical centre for treating patients with cardiac rhythm abnormalities in Calgary, Alberta, has become the first facility in Canada to use the...

July 3, 2008 - A unanimous federal jury in Texas recently found that two patents exclusively licensed to Pressure Products Medical Supplies Inc., which cover medical products called valved peel-...

March 11, 2008 - Sorin Group's ELA Medical received the FDA’s approval to market ISOLINE, a new defibrillation lead designed with redundant insulation and abrasion resistant materials for...

March 3, 2008 - Boston Scientific Corp. received CE Mark approval of its ACUITY Spiral left ventricular lead for use with cardiac resynchronization therapy defibrillators and cardiac...

October 16, 2007 – Medtronic Inc. said in a statement that it has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for...

October 16, 2007 — In response to Medtronic’s decision to voluntarily suspend its Sprint Fidelis defibrillation leads, the Heart Rhythm Society (HRS) made a statement to underscore the importance...

September 18, 2007- With PET-guided lead placement, cardiac resynchronization therapy (CRT) can achieve significant clinical improvement in patients with severe ischemic heart failure, even in the...

May 11, 2007 — St. Jude Medical Inc. has announced FDA approval of its new OptiSense lead, a first-of-its-kind "smart" pacing lead designed to offer more accurate sensing in the upper chamber of...