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 wrongdoing, to settle that case in November 2014. The allegations, made in a qui tam lawsuit filed by Brian Sant, include charges that the company paid doctors in Nevada and Arizona to either continue to use or to convert to using Biotronik pacemakers, defibrillators and cardiac resynchronization therapy devices. The alleged inducements included “repeated meals at expensive restaurants” and “inflated payments for membership on a physician advisory board,” prosecutors said at the time. The disposition of the Sant case led a three-judge panel on the 9th Circuit to a 2-1 ruling Dec. 1 that Bennett’s later lawsuit was precluded by the government-action bar prohibiting whistleblowers from filing qui tam lawsuits “based upon allegations or transactions that are the subject of a civil suit in which the government ‘is alrea...
Source: Mass Device - Category: Medical Devices Authors: Tags: Legal News Biotronik Cardiac Rhythm Management Whistleblower (qui tam) lawsuit Source Type: news

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Cardiac resynchronization therapy (CRT) has been associated to left ventricle (LV) remodelling, reduction of functional mitral regurgitation (FMR) and clinical improvement in patients with heart failure and reduced ejection fraction (HFrEF). The prevalence of significant FMR in patients with LV dyssynchrony that are candidate to CRT is up to 40%. Current approach in patients with FMR undergoing CRT consists of re-evaluation of the amount of FMR following a waiting period of at least 3  months after the implant.
Source: International Journal of Cardiology - Category: Cardiology Authors: Source Type: research
Conclusions: CRT-D has higher greater cost-effectiveness across more subgroups in the indicated patient populations against as compared to OPT, ICD and CRT-P, from a US payer perspective. PMID: 32207659 [PubMed - as supplied by publisher]
Source: Journal of Medical Economics - Category: Health Management Tags: J Med Econ Source Type: research
Condition:   Heart Failure Interventions:   Procedure: Temporary pacing Study;   Radiation: Thoracic CT;   Diagnostic Test: Acute hemodynamic study;   Diagnostic Test: Non-invasive body surface mapping;   Diagnostic Test: Invasive catheter-based mapping Sponsors:   Guy's and St Thomas' NHS Foundation Trust;   King's College London Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
ConclusionsTherapy with CRT-D compared to CRT-P resulted in an additional gain of QALYs, but was more expensive. In addition, the ICER was subject to uncertainty, especially due to the uncertainty in the survival benefit. A randomised controlled trial and subgroup analyses would be desirable to further inform decision making.
Source: Applied Health Economics and Health Policy - Category: Health Management Source Type: research
Publication date: Available online 23 March 2020Source: Canadian Journal of CardiologyAuthor(s): F. Daniel Ramirez
Source: Canadian Journal of Cardiology - Category: Cardiology Source Type: research
Abstract BACKGROUND: The impact of left ventricular reverse remodeling (LVRR) on the prognosis of Chagas cardiomyopathy is unknown. The aim of this study was to determine whether the presence of LVRR can predict mortality in these patients. METHODS: From January 2000 to December 2010, the medical charts of 159 patients were reviewed. LVRR was defined as an increase of left ventricular ejection fraction (LVEF) and a decrease of left ventricular end-diastolic diameter (LVDD) by two-dimensional echocardiography. No patient underwent cardiac resynchronization therapy or required mechanical ventricular assistance....
Source: Cardiology Journal - Category: Cardiology Authors: Tags: Cardiol J Source Type: research
AbstractBackgroundCardiac resynchronization therapy(CRT) is an important and effective therapy for end ‐stage heart failure. Non‐response to CRT is one of the main obstacles to its application in clinical practice. Herein, we investigated the utilization of the optimization technique using NICOM based Mobil‐O‐Graph device which measures several circulation parameters non‐invasively.MethodsSeventy ‐five CRT non‐responder heart failure patients with an implanted CRT device were included. Patients were randomized equally to 3 groups: NICOM, echocardiographic and empirical optimization groups. After 3‐months of...
Source: Pacing and Clinical Electrophysiology : PACE - Category: Cardiology Authors: Tags: DEVICES Source Type: research
AbstractBackgroundPermanent right ventricular pacing (RVP) results in cardiac dyssynchrony that may lead to heart failure and may be an indication for the use of cardiac resynchronization therapy (CRT). The study aimed to evaluate predictors of outcomes in patients with pacing ‐induced cardiomyopathy (PICM) if upgraded to CRT.Methods115 patients, 75.0 years old (IQR 67.0 –80.0), were upgraded to CRT due to the decline in left ventricle ejection fraction (LVEF) caused by the long‐term RVP. A retrospective analysis was performed using data from hospital and outpatient clinic records and survival data from the natio...
Source: Pacing and Clinical Electrophysiology : PACE - Category: Cardiology Authors: Tags: DEVICES Source Type: research
Exercise oscillatory ventilation (EOV) is characterized by ventilatory control system instability with typical waxing and waning of tidal volume without interposed apnea during exercise.1 EOV has been observed in up to 50% of heart failure (HF) patients with similar frequency for those with either reduced2 or preserved3 left ventricular ejection fraction (LVEF). EOV has also been associated with increased mortality risk in HF patients with either reduced4 or preserved LVEF.3
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Source Type: research
Injury to the cardiac venous structures can complicate left ventricular lead placement for cardiac resynchronization therapy (CRT). Little is known about the outcomes of coronary sinus (CS) dissection with or without perforation.
Source: Heart Rhythm - Category: Cardiology Authors: Source Type: research
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