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Medtronic launches Beacon HF monitoring service
Medtronic (NYSE:MDT) said today it launched its Beacon heart failure management service in the U.S., designed to monitor data from cardiac pacing devices to improve early interventions before heart failure events. The service, which integrates data from the company’s implantable cardioverter defibrillator and cardiac resynchronization therapy devices, will allow patients to engage in daily health checks to both educate patients about conditions and to collect symptoms and biometrics. “Beacon is a significant advance in our heart failure management arsenal. With its combination of valuable device diagnostics, ...
Source: Mass Device - June 28, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Patient Monitoring Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 22, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters. 5. J&J investor relations veep Mehrotra retires, Wolk steps up Johnson & Johnson said today its 10-year vice president of investor relations Louise Mehrotra will retire, effective January 2017, to be replaced by Joseph Wol...
Source: Mass Device - June 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

FDA warns Medtronic’s Tyrx on anti-bacterial envelopes
The FDA sent a warning letter earlier this month to Medtronic (NYSE:MDT) subsidiary Tyrx over problems with its process validation and quality systems. The Tyrx envelopes are designed to elute a pair of anti-microbial drugs, minocycline and rifampin, for 7 days before dissolving over a period of roughly 9 weeks. They’re cleared for use with pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization therapy devices, deep-brain stimulators, sacral nerve stimulators, spinal cord stimulators and vagus nerve stimulators. Tyrx, which Medtronic acquired for $160 million in January 2014, won CE Mark...
Source: Mass Device - June 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Regulatory/Compliance Surgical Medtronic TYRX Inc. Warning Letter Source Type: news

Leadless CRT Alternative Slated For U.S.-based Clinical Trial In 2017
New technology that can wirelessly resynchronize the chambers of the heart is making its way toward U.S.-based clinical trials in early 2017. EBR Systems’ WiSE technology is an endocardial pacing system for cardiac resynchronization therapy (CRT), designed to address flaws in conventional CRT systems that are ineffective in one-third of eligible heart failure (HF) patients. (Source: Medical Design Online News)
Source: Medical Design Online News - June 7, 2016 Category: Medical Equipment Source Type: news

HRS 2016 roundup: Leadless pacers at the fore
Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ), aiming to distinguish their respective leadless pacemaker offerings, presented new data last week in San Francisco at the Heart Rhythm Society’s annual meeting. St. Jude said a subset of data from the Leadless II trial showed that its Nanostim device was was successfully retrieved in 14 patients up to 3.2 years after implantation, with no serious adverse events. “We’ve now shown that for patients requiring device upgrades or new leadless pacing options, late retrievability – even up to 3 years – is possible with the Nanostim leadless pacemak...
Source: Mass Device - May 9, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Boston Scientific Cardiac Rhythm Management HRS 2016 Medtronic St. Jude Medical Source Type: news

St. Jude expands EnSite Precision launch in EU, seeks FDA approval
St. Jude Medical (NYSE:STJ) said today it is expanding its commercial release of its EnSite Precision cardiac mapping system in the European Union, and that it is currently pursuing FDA clearance of the system. The St. Paul, Minn.-based company’s Ensite cardiac mapping system is designed for use in ablation procedures to visualize and aid in catheter navigation in the heart, providing detailed anatomical models and maps. The system is designed to aid in diagnosing arrhythmias, guiding therapy and providing expanded procedural options. “We developed the EnSite Precision system with insight from world-renowned e...
Source: Mass Device - April 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blog St. Jude Medical Source Type: news

St. Jude Medical Announces Launch And First US Implants Of MultiPoint Pacing Technology
St. Jude Medical, Inc. , a global medical device company, recently received U.S. Food and Drug Administration (FDA) approval of the company’s proprietary, first-to-market MultiPoint Pacing technology and today announced the U.S. launch and first U.S. implants of the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D). (Source: Medical Design Online News)
Source: Medical Design Online News - April 19, 2016 Category: Medical Equipment Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 18, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters. 5. St. Jude Medical touts 1st U.S. commercial implantations for Quadra Assura with MultiPoint pacing St. Jude Medical today touted the 1st U.S. commercial implantations for its Quadra Assura MP cardiac resynchronization therapy de...
Source: Mass Device - April 18, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

St. Jude Medical touts 1st U.S. commercial implantations for Quadra Assura with MultiPoint pacing
St. Jude Medical (NYSE:STJ) today touted the 1st U.S. commercial implantations for its Quadra Assura MP cardiac resynchronization therapy defibrillator, featuring its MultiPoint pacing technology. The MultiPoint tech is the 1st to hit the U.S. market that allows physicians to tailor pacing therapy by controlling multiple pulses to the left ventricle for each heartbeat. Each lead in the system can deliver 2 pulses per heartbeat, St. Jude said. Last month the Little Canada, Minn.-based company won CE Mark approval in the European Union for 3 new Quartet left ventricular leads; in February, St. Jude said the FDA approve...
Source: Mass Device - April 18, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Wall Street Beat Cardiac Rhythm Management St. Jude Medical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 29, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters. 5. The exodus of key personnel at Google’s Verily There’s reportedly a rare exodus under way of key personnel from a Google operation, its Verily healthcare “moonshot,” with former employees blaming the mercurial leadership...
Source: Mass Device - March 29, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

St. Jude wins CE Mark for expanded suite of cardiac leads
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union and launched 3 new Quartet left ventricular leads. The newly released leads are designed for more effective targeting of individual cardiac anatomies for patients who require cardiac resynchronization therapy pacers and defibs, the company said. “Heart and blood vessel anatomy vary from patient to patient so having multiple sizes and spacing options with the Quartet quadripolar lead helps me to treat all of my patients in need of cardiac resynchronization therapy. We are now able to place the quadripolar lead in the best possible lo...
Source: Mass Device - March 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance St. Jude Medical Source Type: news

Boston Scientific Wins FDA Approval For Quadripolar Leads, Initiates Trial To Expand MRI Labeling
Boston Scientific FDAapproval for the ACUITYX4 Quadripolar Left Ventricular (LV) leads. The FDA approval of the quadripolar leads, the wires that connect cardiac resynchronization therapy (CRT) devices to the heart, marks the first time the company will offer a full X4 CRT system – both the device and the leads – to the U.S. market. (Source: Medical Design Online News)
Source: Medical Design Online News - February 25, 2016 Category: Medical Equipment Source Type: news

Boston Scientific Receives U.S. FDA Approval For Quadripolar Leads And Initiates Global Trial To Expand MRI Labeling To The U.S. And Asia
FDA-Approved ACUITY X4 Quadripolar Left Ventricular Leads to be used in Trial Pursuing MRI Labeling for Cardiac Defibrillation and Resynchronization Systems MARLBOROUGH, Mass., Feb. 23, 2016 -- (Healthcare Sales & Marketing Network) -- Boston Scientif... Devices, Cardiology, FDABoston Scientific, Quadripolar Leads, cardiac resynchronization therapy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 23, 2016 Category: Pharmaceuticals Source Type: news

Medtronic Receives CE Mark for Full Line of Cardiac Resynchronization Therapy-Defibrillators Compatible with MRI Scans
Medtronic plc (NYSE:MDT) today announced that it has received CE (Conformité Européenne) Mark for the first and only cardiac resynchronization therapy defibrillators (CRT-Ds) approved for 3 Tesla (T) magnetic resonance imaging (MRI) scans, providing CRT-D patients with access to the most advanced imaging diagnostic procedures available. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 23, 2016 Category: Cardiology Source Type: news

Medtronic wins CE Mark for line of MR-safe CRT-Ds
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its full line of magnetic resonance imaging safe cardiac resynchronization therapy defibrillators, now approved for use with 3 Tesla MRI machines. The approval includes Fridley, Minn.-based Medtronic’s Claria MRI quad CRT-D SureScan, Amplia MRI quad CRT-D and Compia MRI quad systems, which are also approved for lower-power 1.5 Tesla scanners. “The ability to provide CRT-D patients with access to MRI scans is a significant, necessary advancement that may help save lives. The most common magnetic field strength for an MRI is 1.5T, ...
Source: Mass Device - February 22, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Clearance Medtronic Source Type: news