What 's the Worst Case Scenario for AtriCure 's Federal Investigation?

Renewed concerns about a Department of Justice (DoJ) investigation involving a key player in the atrial fibrillation space has prompted one medtech analyst to review similar investigations in the industry. In March 2018, Mason, OH-based AtriCure, disclosed that it received a civil investigative demand from the DoJ over potential off-label marketing of the company's Deep hybrid procedure products, which account for about 10% of AtriCure's total sales. AtriCure's Deep procedure is not FDA approved to treat atrial fibrillation, but the devices that are used in the procedure have FDA clearances for tissue ablation and the company is currently running a trial to support approval for an atrial fibrillation indication. It should also be noted that this isn't AtriCure's first DoJ investigation. The agency investigated AtriCure several years back for off-label marketing, physician kickbacks, and reimbursement fraud. The company ended up paying nearly $3.8 million to settle the allegations and signed a five-year corporate integrity agreement (CIA) that ended in early 2015.  What_s_the_Worst_Cas.mp4     According to Needham &Co.'s Mike Matson, prior investigations involving medical device companies accused of physician kickbacks, reimbursement errors (improper coding), and/or off-label marketing took a median of 2.5 years and a median fine of $13 million to ...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Regulatory and Compliance Source Type: news

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Publication date: Available online 19 October 2019Source: Life SciencesAuthor(s): Lu Fu, Fang Rao, Feihong Lian, Hui Yang, Sujuan Kuang, Shulin Wu, Chunyu Deng, Yumei XueAbstractAimsTo explore the atrial electrical remodeling and the susceptibility of atrial fibrillation (AF) in diabetic rats.Materials and methodsZucker diabetic fatty (ZDF) rats were chosen as diabetic animal model, and age-matched non-diabetic littermate Zucker lean (ZL) rats as control. AF susceptibility was determined by electrophysiological examination. The current density of Ito, IKur and ICa-L were detected by whole-cell patch-clamp technique, and io...
Source: Life Sciences - Category: Biology Source Type: research
This study assessed patient preference for warfarin or DOAC based on a willingness to pay more for potential DOAC benefits. Current warfarin patients with atrial fibrillation or venous thromboembolism enrolled in the University of Utah Health Thrombosis Service were given a one-time electronic survey that assessed preferences between warfarin and DOACs using scenarios comparing effectiveness, safety, and convenience. When DOACs were preferred, patients were asked how much more they would be willing to pay monthly for the perceived advantages associated with DOACs. With 123 completed surveys, 68% of patients preferred to st...
Source: Journal of Thrombosis and Thrombolysis - Category: Hematology Source Type: research
AbstractVery limited but promising experiences with the use of direct factor Xa inhibitors for the treatment of heparin-induced thrombocytopenia (HIT) have been reported. This contribution features our first experience with the use of apixaban (without a pre-treatment with parenteral anticoagulant) to treat a case of HIT which developed in a patient after multiple heart replacement surgery. Apixaban was effective, well tolerated and safe. An apixaban-calibrated chromogenic anti-Xa activity assessment was used to monitor apixaban activity throughout the therapy. Patient continued on apixaban for the prevention of thrombosis...
Source: Journal of Thrombosis and Thrombolysis - Category: Hematology Source Type: research
Atrial fibrillation (AF), a risk factor for strokes and systemic thromboembolisms, is associated with unfavorable fibrin clot properties and increased thrombus formation in peripheral blood. The left atrial appendage (LAA) is known to be the primary site of thrombus formation.
Source: International Journal of Cardiology - Category: Cardiology Authors: Source Type: research
Pacing and Clinical Electrophysiology, Volume 0, Issue ja, -Not available-.
Source: Pacing and Clinical Electrophysiology : PACE - Category: Cardiology Authors: Tags: LETTER TO EDITOR ‐ RESPONSE Source Type: research
Publication date: Available online 18 October 2019Source: IJC Heart &VasculatureAuthor(s): Dominik Linz, Mathias Baumert, Lien Desteghe, Kadhim Kadhim, Kevin Vernooy, Jonathan M. Kalman, Dobromir Dobrev, Michael Arzt, Manu Sastry, Harry J.G.M. Crijns, Ulrich Schotten, Martin R. Cowie, R. Doug McEvoy, Hein Heidbuchel, Jeroen Hendriks, Prashanthan Sanders, Dennis H. LauAbstractIn patients with atrial fibrillation (AF), the prevalence of moderate-to-severe sleep-disordered breathing (SDB) ranges between 21% and 72% and observational studies have demonstrated that SDB reduces the efficacy of rhythm control strategies, whil...
Source: IJC Heart and Vasculature - Category: Cardiology Source Type: research
CONCLUSIONS: Investigators failed to find ample support for routine use of NPWT as a “bridge to reconstruction.” Serious complications related to the use of NPWT including right ventricular rupture, atrial fibrillation, respiratory arrest, recurrent infection, and a retained sponge were reported in this group of studies. Rigorous evaluative studies that assess the true effectiveness of NPWT as a “bridge to reconstruction” must precede its adoption.
Source: Advances in Skin and Wound Care - Category: Dermatology Tags: FEATURES: LITERATURE REVIEW Source Type: research
It turns out that how often you drink affects the chances of developing an irregular heartbeat known as atrial fibrillation (AFib) more than the amount or volume of alcohol consumed, according to the findings of a new study.
Source: Forbes.com Healthcare News - Category: Pharmaceuticals Authors: Source Type: news
Publication date: Available online 7 October 2019Source: Pathology - Research and PracticeAuthor(s): Dominik Gross, Christina LaursAbstractThe Jewish pathologist Carl Julius Rothberger (1871–1945) is undoubtedly one of the most important representatives of his field. His studies on atrial fibrillation, the bundle branch block and arrhythmia perpetua in particular secured him a place in medical history. Rothberger also gave the name to an agar used to prove the neutral red reduction of salmonella (Rothberger-Scheffler agar).While Rothberger’s name is well known in pathology, his biography and his experiences of ...
Source: Pathology Research and Practice - Category: Pathology Source Type: research
ConclusionsOur findings indicate that Arnebiae Radix treatment can attenuate Ach-CaCl2-induced atrial injury and serve as an effective therapeutic strategy for the treatment of AF in the future.Graphical abstract
Source: Journal of Ethnopharmacology - Category: Drugs & Pharmacology Source Type: research
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