How Is Cardiac Resynchronization Therapy Done?
Title: How Is Cardiac Resynchronization Therapy Done?Category: Procedures and TestsCreated: 4/22/2020 12:00:00 AMLast Editorial Review: 4/22/2020 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - April 22, 2020 Category: Cardiology Source Type: news

Abbott Continues to Show Heart with ‘Breakthrough’ Announcement
Abbott Laboratories continues to extend its list of milestones in the cardiovascular space. The Abbott Park, IL-based company has now won Breakthrough Device Designation from FDA for the in-development Fully Implantable Left Ventricular Assist System (FILVAS). FILVAS builds on the HeartMate 3 Left Ventricular Assist Device (LVAD). The technology was inherited by St. Jude Medical when it was acquired by Abbott. St. Jude inherited Heartmate 3 after it acquiredThoratec for $3.4 billion. Kevin Bourque, Divisional Vice President of Research & Development for Abbott’s Mechanical Circulatory Support portfo...
Source: MDDI - February 5, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news

ICDs Have Come a Long Way in 40 Years
Michel Mirowski and his colleagues gave the field of implantable cardioverter-defibrillators (ICDs) a pretty good start, but what's more impressive is how far the technology has advanced since that first human ICD implant in February 1980. In the past 40 years we've seen ICDs become dramatically smaller, longer lasting, more capable, more personalized, subcutaneous (non-transvenous), and even MRI-firendly. And that's not to mention the advanced data connectivity and monitoring capabilities that the latest technologies offer. So without further ado, let's take a look at the current ICD landscape and the companie...
Source: MDDI - February 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

Recall of Pacemaker in Nov. 2015 Was Delayed Unnecessarily
FRIDAY, Dec. 27, 2019 -- Recall of a cardiac resynchronization therapy pacemaker, which occurred in November 2015, was delayed unnecessarily, according to a report published online Dec. 20 in JAMA Internal Medicine. Jay Sengupta, M.D., from the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - December 27, 2019 Category: Pharmaceuticals Source Type: news

Biomarkers to Predict the Response to CRT Biomarkers to Predict the Response to CRT
This article reviews the current evidence on promising biomarkers for predicting response to cardiac resynchronization therapy. Are any sufficiently reliable and sensitive?Europace (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 28, 2019 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Pacemakers can improve heart function in patients with chemotherapy-induced heart disease
(Massachusetts General Hospital) Research has shown that treating chemotherapy-induced cardiomyopathy with commercially available cardiac resynchronization therapy (CRT) delivered through a surgically implanted defibrillator or pacemaker can significantly improve patient outcomes. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - November 13, 2019 Category: Cancer & Oncology Source Type: news

Cardiac Resynchronization Therapy Benefits Cancer Survivors with Heart Failure
A pacemaker-like device restored heart function in a group of cancer survivors — mostly women with breast cancer — who had suffered from heart failure as a result of chemotherapy, a study in the Journal of the American Medical Association (JAMA) reports. (Source: University of Rochester Medical Center Press Releases)
Source: University of Rochester Medical Center Press Releases - November 13, 2019 Category: Universities & Medical Training Authors: University of Rochester Medical Center Source Type: news

Cardiac resynchronization therapy benefits cancer survivors with heart failure
(University of Rochester Medical Center) A pacemaker-like device restored heart function in a group of cancer survivors -- mostly women with breast cancer -- who had suffered from heart failure as a result of chemotherapy treatment, a study in the Journal of the American Medical Association (JAMA) reports. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 12, 2019 Category: International Medicine & Public Health Source Type: news

STOP-CRT: Maybe Stop Some HF Meds if CRT Restores Heart Function STOP-CRT: Maybe Stop Some HF Meds if CRT Restores Heart Function
It's only one study, but some highly selected patients might improve on cardiac resynchronization therapy such that RAAS inhibitors and beta blockers are no longer indicated, a researcher says.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 23, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news

Cardiac'Shrinkage' on Sacubitril/Valsartan May Rival CRT in HF Cardiac'Shrinkage' on Sacubitril/Valsartan May Rival CRT in HF
LV volumes fell and LVEF rose, often 10 points or more, after a year on the ARNI. That approaches gains on cardiac resynchronization therapy,"the reverse-remodeling champion," a researcher notes.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - September 11, 2019 Category: Cardiology Tags: Cardiology News Source Type: news

New Data Presented at ESC Congress 2019 Supports ICD Use
This study investigated the association between ICD use and all-cause mortality in a contemporary reduced ejection fraction (HFrEF) cohort with a focus on subgroups. The study population was compiled from patients in the Swedish Heart Failure Registry (SwedeHF) fulfilling ESC criteria for primary prevention ICD use. Propensity score matching was used to account for differences at baseline. In a release principal investigator Dr. Benedikt Schrage of the Karolinska Institute in Stockholm, Sweden said: “Most randomized trials on ICD use for primary prevention of sudden cardiac death in HFrEF enrolled patient...
Source: MDDI - September 3, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

EBR Systems Closes $30M in New Funding, John McCutcheon Joins Company as President and CEO
SUNNYVALE, Calif., Aug. 27, 2019 -- (Healthcare Sales & Marketing Network) -- EBR Systems, Inc., developer of the world's only wireless cardiac pacing system for heart failure, today announced it has closed $30M in new funding to complete enrollment of it... Devices, Cardiology, Venture Capital, Personnel EBR Systems, cardiac pacing, Cardiac Resynchronization Therapy, WISE CRT (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 27, 2019 Category: Pharmaceuticals Source Type: news

Some Heart Failure Patients May Benefit From CRT Defibrillator
THURSDAY, June 20, 2019 -- Cardiac resynchronization therapy with defibrillator (CRT-D) implantation is associated with better outcomes than an implantable cardioverter-defibrillator (ICD) for patients with nonspecific intraventricular conduction... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 21, 2019 Category: Pharmaceuticals Source Type: news

CRT defibrillator may help more heart failure patients
For patients with heart abnormalities that can't be fixed with a normal defibrillator, a cardiac resynchronization therapy with defibrillator may help with the problem. (Source: Health News - UPI.com)
Source: Health News - UPI.com - June 18, 2019 Category: Consumer Health News Source Type: news

Cardiac MRI in Patients With Cardiac Resynchronization Therapy Cardiac MRI in Patients With Cardiac Resynchronization Therapy
This article presents a strategy for conducting high quality scans safely.Europace (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - May 17, 2019 Category: Radiology Tags: Cardiology Journal Article Source Type: news

FDA Flags Battery Issue Impacting Some Medtronic Pacemakers
FDA alerted patients and physicians on Tuesday to a problem that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) to drain more quickly than expected or without warning. Implanted pacemakers and CRT-Ps have electronics and are powered by lithium-ion batteries. One of the key electronic components is a capacitor, which stores electrical energy. Medtronic said there have been three medical device reports in which one of a Medtronic implantable pacemakers or CRT-P battery had fully drained without warning because of a crack in the ...
Source: MDDI - May 8, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

US Physicians Now Treating Patients with BIOTRONIK's Ultraslim Acticor DX Devices
Lake Oswego, Ore., April 29, 2019 /PRNewswire/ -- BIOTRONIK today announced the full commercial launch of the Acticor device family, including Acticor DX and CRT-DX devices. Leading electrophysiologists throughout the United States are now treating patients with the new implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). When implanted with BIOTRONIK's Plexa ProMRI S DX lead, the hybrid ICD Acticor...This story is related to the following:Medical Devices (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - April 30, 2019 Category: Medical Devices Source Type: news

BIOTRONIK Announces First Enrollment in CRT-Next Study
BIOTRONIK has announced first enrollment in a multicenter study that aims to demonstrate that a two-lead cardiac resynchronization therapy (CRT) system with atrial sensing is at least as effective as a conventional three-lead system. BIOTRONIK's CRT-DX technology provides therapy through two ventricular leads and features a floating dipole for complete atrial diagnostics without an additional lead. (Source: eHealth News EU)
Source: eHealth News EU - January 28, 2019 Category: Information Technology Tags: Featured Industry Business and Industry Source Type: news

CRT in Heart Failure: Is the Defibrillator Needed? CRT in Heart Failure: Is the Defibrillator Needed?
Questions still remain as to the additive benefit of the defibrillator as an adjunct to cardiac resynchronization therapy.Europace (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 17, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

BioCardia Developing Comprehensive Approach to Treat Heart Failure
It can be a bit trick when trying to put BioCardia’s cell therapy for heart failure in one specific category. Is the CardiAmp Cell Therapy a diagnostic, device, or a biologic? Perhaps it’s all of the above. The San Carlos, CA-based company’s president and CEO painted a clearer picture for the technology noting that it could play a significant role when looking at heart failure treatment. “The [CardiAMP Cell Therapy System] is regulated by the agency [FDA] as a combination product via an IDE PMA device pathway,” Peter Altman, BioCardia...
Source: MDDI - November 16, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

FDA warns Medtronic on CRM plants in Minnesota, Puerto Rico
The FDA this week released warning letters it sent to Medtronic (NYSE:MDT) over issues with cardiac rhythm management plants in Minnesota and Puerto Rico. The federal safety watchdog said inspections in April and May at both plants turned up problems related to the recall of CRM devices over high-voltage arcing, which led to the recall of some 800 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. In January the Fridley, Minn.-based company informed physicians of the recall of 48 of the devices that were “sent through a manufacturing sequence that introduced the po...
Source: Mass Device - September 12, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Warning Letter Source Type: news

Medtronic launches ECG belt HF optimization trial
Medtronic (NYSE:MDT) said today it launched a new clinical trial evaluating the use of its ECG belt research system as a diagnostic tool for improving cardiac resynchronization therapy for heart failure patients. The Fridley, Minn.-based company said it has enrolled the first patients in the trial at Des Moines, Iowa’s Mercy Medical Center – West Lakes by principal investigator Dr. Troy Hounshell. “The aim of this technology is to give physicians immediate feedback that may impact clinical decision making at the time of implant and also during follow-up visits. By pairing CRT with the ECG Belt, we ha...
Source: Mass Device - July 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Medtronic Source Type: news

Thousands of Medtronic CRM devices need software upgrades
The FDA this week released notices from Medtronic (NYSE:MDT) warning of software issues with approximately 41,000 cardiac rhythm management devices. The warnings affect approximately 29,000 EnTrust and Escudo implantable cardioverter defibrillator devices and approximately 12,000 Percepta and Percepta Quad cardiac resynchronization therapy devices, according to urgent field notices sent out by the Fridley, Minn.-based company in June. The recalls have been labeled as Class 2 by the FDA, and no deaths have been reported related to the issues, according to Medtronic. The company said that its EnTrust and Escudo ICDs may...
Source: Mass Device - July 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Medtronic Source Type: news

Medtronic & #039;s Value-Based Partnerships are Paying Off in Spades
Dublin, Ireland-based Medtronic continues to lead the charge toward value-based care, and it's beginning to pay off in a big way.  One of the company's value-based care partners, UnitedHealthcare, has seen a 27% decline in the rate of preventable hospital admissions for Medtronic insulin pump users compared to patients on multiple daily insulin injections, according to an analysis of more than 6,000 members with diabetes on Medtronic MiniMed 630G and previous generation insulin pumps. And that's just in the first year of the partnership. The analysis included a mix of members using both standalone insulin pumps and pu...
Source: MDDI - July 11, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Size Might Matter for CRT to Work in Narrow-QRS Heart Failure Size Might Matter for CRT to Work in Narrow-QRS Heart Failure
Should cardiac resynchronization therapy indications consider ventricular size with narrower QRS intervals? It's'pretty bold'to suggest the guidelines might need revising, said an observer.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 12, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

MicroPort < sup > ® < /sup > CRM Announces PMDA Approval in Japan of PLATINIUM ™ 4LV SonR < sup > ® < /sup > CRT-D < br > < span style= " font-size:14px; line-height:22px; " > < i > PLATINIUM ™ 4LV SonR* combines quadripolar IS-4 left ventricular pacing options with SonR, the world's first and only sensor-based therapeutic optimization, for cardiac resynchronization therapy. < /i > < /span >
(Source: Microport News Release)
Source: Microport News Release - June 3, 2018 Category: Medical Devices Source Type: news

Medtronic touts improved patient survival in AdaptivCRT algorithm study
Medtronic (NYSE:MDT) today released results from a study of its AdaptivCRT algorithm, touting that the use of the algorithm increased patient survival. Results from the trial were presented last week at the Heart Rhythm Society’s annual scientific sessions in Boston, the Fridley, Minn.-based company said. The AdaptivCRT algorithm is designed to personalize cardiac resynchronization therapy and adjusts how implanted CRT devices pace the heart according to evaluations of the patient’s heart rhythm, Medtronic said. In the AdaptResponse prospective registry study, researchers explored the use of the Adapt...
Source: Mass Device - May 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Medtronic Source Type: news

Recognizing Left Bundle Branch Block and When It Matters Recognizing Left Bundle Branch Block and When It Matters
These Mayo Clinic experts illustrate how to identify LBB on ECG, what measures to take to correct it, and novel developments in cardiac resynchronization therapy.Mayo Clinic (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 30, 2018 Category: Consumer Health News Tags: Cardiology Roundtable Source Type: news

Abbott releases cybersecurity, battery update for high-voltage implantable cardiac devices
Abbott (NYSE:ABT) today announced a firmware upgrade for its high-voltage implantable cardiac devices looking to shore up cybersecurity and improve battery performance. The company stated that while the update is intended to improve cybersecurity through an additional layer of protection against unauthorized device access, it has not received any reports that any of its devices have been exploited remotely. Abbott also said that it has not identified any new vulnerabilities in its cardiac device portfolio. The newly released firmware upgrade includes an enhanced device-based battery performance alert, Abbott said...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Abbott Source Type: news

CMS approves expanded MRI coverage for CRM patients
The Centers for Medicare & Medicaid Services have finalized a plan that will cover magnetic resonance imaging scans for patients with implanted cardiac devices, including pacemakers, cardioverter defibrillators and cardiac resynchronization therapy devices, according to a MedPage Today report. The finalized decision, which was released in January, will allow Medicare patients with MR-conditional devices to have their MRI scans covered by the national healthcare program. Patients with non-MR-conditional devices will also be reimbursed, but only when the MRI machine is 1.5 Tesla or less in normal operating mode, accordin...
Source: Mass Device - April 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Imaging Wall Street Beat Centers for Medicare and Medicaid Services (CMS) Source Type: news

Medtronic touts reduced AF, improved activity in AdaptivCRT studies
Medtronic (NYSE:MDT) today released results from two real-world analyses of its AdaptivCRT algorithm, touting that its use was linked to a reduction in atrial fibrillation episodes and higher patient activity levels. Results from the analyses, which involved a total of 408 patients at 26 centers in Italy, were presented at the European Heart Rhythm Association’s Scientific Sessions 2018 in Barcelona, Spain, the company said. Medtronic’s AdaptivCRT algorithm is designed to adjust pacing to the heart dependent upon evaluations of heart rhythm made every minute, the company said. The program has been sho...
Source: Mass Device - March 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Software / IT Medtronic Source Type: news

Medicare: Hospitals mishandled warranty credits for recalled cardiac devices
A number of US Hospitals have failed to appropriately pay Medicare for warranty credits received from cardiac device manufacturers for recalled devices, according to a new report from the Dept. of Health and Human Services Office of Inspector General. In the report, a total of 296 payments for recalled cardiac devices were reviewed, and all were found to have not complied with Medicare requirements for reporting manufacturing credits resulting in a total of $4.4 million in overpayments from CMS. The reported payments came from 210 hospitals investigated in the report which performed procedures to replace defective or recal...
Source: Mass Device - March 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Centers for Medicare and Medicaid Services (CMS) Dept. of Health & Human Services (HHS) Source Type: news

EBR Systems launches trial for wireless pacer
EBR Systems said yesterday that it launched a 350-patient investigational device exemption trial of its Wise wireless pacemaker it hopes to use to win FDA approval. Sunnyvale, Calif.-based EBR’s device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses to synchronize the left and right ventricles. The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pellet” in a patient-specific location inside the left ventricle. The FDA approv...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Cardiac Rhythm Management EBR Systems Inc. Source Type: news

Class I Medical Device Recall: Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery https://go.usa.gov/xnzxy   #MedicalDevice
Class I Medical Device Recall: Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery https://go.usa.gov/xnzxy  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 1, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Medtronic recalls 48 CRM devices on arcing risk
Medtronic (NYSE:MDT) informed physicians last month of a problem with 48 of its cardiac rhythm management devices that’s prompting a Class I recall of the devices. The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were “sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading to the immediate and permanent loss of device functionality,” according to a January doctors letter from quality & regulatory VP Tim Samsel. The issue led to a single instance in which an implant...
Source: Mass Device - February 27, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Recalls Regulatory/Compliance Cardiac Rhythm Management Medtronic Source Type: news

Medtronic is Making the Most of Value-Based Care
Medical device companies of all sizes have embraced value-based healthcare in recent years, and one of the industry's top companies is now beginning to see its value-based care programs pay off. "I know I have spoken a lot about value-based healthcare, but I'm particularly pleased to see this translate into real numbers, which have real differentiating value for Medtronic," CEO Omar Ishrak said during Medtronic's third-quarter earnings call Tuesday, according to Seeking Alpha transcripts. Learn more about the future of innovation in the value-based care system at the BIOMEDevice Boston conference, April 18-1...
Source: MDDI - February 20, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Source Type: news

CMS mulls expanded MRI coverage for CRM patients
The Centers for Medicare & Medicaid Services is thinking about extending coverage for magnetic resonance imaging scans to patients with cardiac rhythm management devices after reviewing studies showing that MRI scans are safe. If finalized the decision would allow Medicare patients with implanted MR-conditional devices such as pacemakers or defibrillators to have their MRI scans covered by the national healthcare program. “We propose that the evidence is sufficient to conclude that magnetic resonance imaging (MRI) for Medicare beneficiaries with an implanted pacemaker (PM), implantable cardioverter defibrillator ...
Source: Mass Device - January 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Wall Street Beat Cardiac Rhythm Management Centers for Medicare and Medicaid Services (CMS) Source Type: news

Sensor glitch prompts Boston Scientific warning on pacemakers
Boston Scientific (NYSE:BSX) last month warned physicians of a sensor glitch with some of its pacemakers that could lead to fainting episodes. In a December “Dear Doctor” letter, Marlborough, Mass.-based Boston Scientific said it received reports of “intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems.” The problem can occur with any company’s pacing leads, but an internal investigation showed that it was most likely to happen with right atrium or right ventricle leads made b...
Source: Mass Device - January 12, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Recalls Boston Scientific Cardiac Rhythm Management Source Type: news

Abbott Expands Portfolio of MRI-Ready Devices
FDA gave MR-conditional labeling to two of Abbott's cardiac rhythm management (CRM) devices, a move that further boosts the company's ability to compete with its peers in the space. The Abbott Park, IL-based firm said patients who receive a Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D) or a Fortify Assura implantable cardioverter defibrillator (ICD) are now able to have an MRI in the future if need be. The Quadra Assura and the Fortify Assura are two of Abbott's most widely-used high voltage devices, the company noted. In September 2016, Abbott won FDA approval for MR-conditional labeling for the...
Source: MDDI - January 3, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Regulatory and Compliance Source Type: news

Abbott gains on Morgan Stanley upgrade, touts MR conditional FDA labeling
Abbott (NYSE:ABT) shares have risen approximately 1.3% after the company received an upgrade from a Morgan Stanley analyst and won updated MR-conditional labeling from the FDA for two of its cardiac pacing devices. The share price rise came after Morgan Stanley analyst David Lewis yesterday lifted the price target for the company from $60 to $67, according to a Benzinga report. The lift was due to the company’s device pipeline, including tis Libre and Confirm devices, which Lewis said could drive organic revenue growth acceleration to greater than 6%, according to the report. Lewis said that that strength, along...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news

Appeals court tosses whistleblower suit against Biotronik
The plaintiff in a whistleblower lawsuit against Biotronik only gets one bite at the apple, a federal appeals court ruled last week in tossing the False Claims Act suit. The U.S. Court of Appeals for the Ninth Circuit upheld the dismissal of the second lawsuit brought by Max Bennett, a former Biotronik employee who alleged that the company ran a kickbacks scheme to entice doctors into using its cardiac rhythm management products. Bennett had filed his first suit shortly after another ex-Biotronik worker’s suit made similar allegations. Biotronik agreed to pony up $4.9 million, but admitted no wrongdoin...
Source: Mass Device - December 4, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Biotronik Cardiac Rhythm Management Whistleblower (qui tam) lawsuit Source Type: news

How Medtronic & #039;s Pacemakers Are Now Harder to Hack
FDA approved Medtronic's Azure pacemakers, which feature the company's new BlueSync technology to protect patients from having their device hacked. The BlueSync technology is also now available with the Medtronic Percepta portfolio of quadripolar, MR-conditional cardiac resynchronization therapy pacemakers (CRT-Ps), the company said. BlueSync is intended to enable more secure wireless remote monitoring via Medtronic's CareLink Network, by limiting access to the device functionality and also by protecting patient data. Connected medical devices like pacemakers add value to patient care by enabling remote patient monito...
Source: MDDI - November 21, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Cardiovascular Source Type: news

Why LivaNova Is Unloading Its CRM Business
LivaNova, formerly known as Sorin Group, has decided to get out of the cardiac rhythm management (CRM) business and shift more focus to its areas of strength.  The London-based company plans to sell its CRM business to Shanghai-based MicroPort for $190 million in cash. The business, which makes high-voltage defibrillators, cardiac resynchronization therapy devices and low-voltage pacemakers, generated about $249 million in net sales in the fiscal year 2016. The business has roughly 900 employees with operations chiefly in Clamart, France; Saluggia, Italy; and Santo Domingo, Dominican Republic. The company said in Sept...
Source: MDDI - November 20, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Medical Device Business Source Type: news

Medtronic wins FDA nod for Azure remote monitoring equipped pacers
Medtronic (NYSE:MDT) said today it won FDA approval for its portfolio of Azure pacemakers with BlueSync patient monitoring technology. The clearances cover both the Azure XT MRI and Azure S MRI pacers including single chamber and dual chamber models, the Fridley, Minn.-based company said. The newly cleared pacers have estimated lifespans of 13.7 years for dual chamber pacers, which Medtronic estimates is 27% longer than the earlier-gen devices. The Azure portfolio of pacers feature the company’s Reactive ATP algorithm intended to slow the progression of atrial fibrillation and BlueSynch technology which allows f...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Source Type: news

EBR Systems pulls in $50m for wireless pacer
EBR Systems said yesterday that it raised $50 million to back a clinical trial for the wireless cardiac pacemaker it’s developing after winning CE Mark approval for a second-generation wireless transmitter. EBR’s device, which it calls wireless stimulation endocardially or Wise, uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses to synchronize the left and right ventricles. The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pe...
Source: Mass Device - November 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Funding Roundup Regulatory/Compliance Wall Street Beat Cardiac Rhythm Management EBR Systems Inc. Source Type: news

MassDevice.com +5 | The top 5 medtech stories for October 13, 2017
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. 10 tips for selecting and managing a medtech development partner There many things to consider when searching for and interacting with a product development firm – and the stakes are high! Most early-stage medical device ...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic, Mercy hospitals ink data-sharing deal
Medtronic (NYSE:MDT) and the Mercy healthcare system today said they inked a data sharing and analysis deal to gather clinical evidence for “medical device innovation and patient access.” The program aims to gather efficacy and safety data generated during routine care, rather than via expensive and time-consuming clinical trials. The first phase is designed to collect anonymized data from some 80,000 heart failure patients treated with cardiac resynchronization therapy. “Having the ability to study patient care pathways and conditions before and after exposure to a medical device is crucial to understand...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Big Data Hospital Care Wall Street Beat Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 25, 2017
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. EY is upbeat about the medical device industry: Here’s why The medical device industry is growing, at a healthy and steady pace. This is according to EY’s Pulse of the Industry report, which was released today at Ad...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Boston Scientific launches MRI-safe Resonate devices with HeartLogic diagnostic in U.S.
Boston Scientific (NYSE:BSX) launched today its Resonate implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems with the HeartLogic heart failure diagnostic tool. The devices are approved by the FDA for conditional use in an MRI environment, the company reported. Boston Scientific’s HeartLogic diagnostic warns doctors of worsening heart failure, collecting data from sensors monitoring heart sounds, thoracic impedance, heart rate and activity and respiration rate and volume. The company touted its alert system as the first and only of its kind in an implantable device w...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat Boston Scientific Source Type: news

Boston Scientific Announces U.S. FDA Approval for MRI Labeling on High-Voltage Devices and U.S. Launch of Resonate(TM) Devices with the HeartLogic(TM) Heart Failure Diagnostic
MARLBOROUGH, Mass., Sept. 25, 2017 -- (Healthcare Sales & Marketing Network) -- Boston Scientific (NYSE: BSX) has launched the Resonate™ family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) sys... Devices, Cardiology, FDA Boston Scientific, Resonate, ICD , CRT-D, SmartCRT, HeartLogic (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 25, 2017 Category: Pharmaceuticals Source Type: news