inHEART Raises $4.2 Million to Improve Treatments for Cardiac Arrhythmias With Medical Imaging, Artificial Intelligence and Numerical Simulations
PESSAC, France, July 2, 2020 -- (Healthcare Sales & Marketing Network) -- inHEART, providing a cloud-based medical image analysis solution for cardiac interventions on patients with arrhythmias, has closed a round of EUR 3.7 million led by Elaia. These fu... Devices, Cardiology, Venture Capital inHEART, cardiac modeling (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - July 2, 2020 Category: Pharmaceuticals Source Type: news

Complications After Colonoscopy Up for Those Aged ≥ 75
Other factors associated with risk include anemia, cardiac arrhythmia, hypertension, smoking history, obesity (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - June 26, 2020 Category: Cancer & Oncology Tags: Gastroenterology, Oncology, Journal, Source Type: news

Critically ill COVID-19 patients are 10 times more likely to develop cardiac arrhythmias
(University of Pennsylvania School of Medicine) Patients with COVID-19 who were admitted to an intensive care unit were 10 times more likely than other hospitalized COVID-19 patients to suffer cardiac arrest or heart rhythm disorders, according to a new study. Researchers say the results suggest that cardiac arrests and arrhythmias suffered by some patients with COVID-19 are likely triggered by a severe, systemic form of the disease and are and not the sole consequence of the viral infection. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - June 22, 2020 Category: Infectious Diseases Source Type: news

Many COVID-19 Prophylaxis Trials Lack ECG Screening Many COVID-19 Prophylaxis Trials Lack ECG Screening
Many COVID-19 trials have not looked at ECGs, either to exclude people at highest risk for a life-threatening cardiac arrhythmia or to flag people who achieve a dangerous QTc interval on treatment.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - May 12, 2020 Category: Cardiology Tags: Cardiology News Source Type: news

Biosense Webster Unveils Late-Breaking Results from PRECEPT Study in Patients with Persistent Atrial Fibrillation
IRVINE, CA – May 8, 2020 – Johnson & Johnson Medical Devices Companies* today announced that Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH® SF Ablation Catheter, evaluated in the PRECEPT study for the treatment of persistent atrial fibrillation (AF), resulted in freedom from any documented, symptomatic atrial arrhythmias at 15 months post-procedure for eight out of ten study participants (80.4 percent).1 Use of the THERMOCOOL SMARTTOUCH SF CATHETER for persistent atrial fibrillation is investigational only. This PRECEPT study data support a Premarket Approval supplement application to the U.S. Fo...
Source: Johnson and Johnson - May 12, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Hydroxychloroquine linked to increased risk of cardiac arrhythmias
(Beth Israel Deaconess Medical Center) In a brief report published today in JAMA Cardiology, a team of pharmacists and clinicians at Beth Israel Deaconess Medical Center (BIDMC), part of Beth Israel Lahey Health, found evidence suggesting that patients who received hydroxychloroquine for COVID-19 were at increased risk of electrical changes to the heart and cardiac arrhythmias. The combination of hydroxychloroquine with azithromycin was linked to even greater changes compared to hydroxychloroquine alone. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 1, 2020 Category: International Medicine & Public Health Source Type: news

The digital diagnostic helper: Apple Watch detects severe coronary ischemia
(Dpt of Cardiology - University Medical Center Mainz) Apple watches have long been able to record electrocardiograms (ECGs) and send warnings in the event of an irregular heart rhythm such as atrial fibrillation. Now a team of cardiologists from the Cardiopraxis Mainz and the Department of Cardiology of the University Medical Center Mainz discovered that, with the help of an Apple Watch, cardiac arrhythmias as well as coronary ischemia can be identified. This is what they reportin the European Heart Journal. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 30, 2020 Category: International Medicine & Public Health Source Type: news

U.S. FDA Approves IMBRUVICA ® (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
HORSHAM, Pa., April 21, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are new to therapy. The approval is based on positive results from the landmark Phase 3 E1912 study that was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health. Today’s mi...
Source: Johnson and Johnson - April 22, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

AZCERT opens access to Medsafety Scan ® for safe prescribing during COVID-19 pandemic
((AZCERT) Arizona Center Center for Education and Research on Therapeutics) AZCERT is making MedSafety Scan ® , a web-based decision support system, available free to medical professionals around the world treating COVID-19 patients. MedSafety Scan can warn healthcare providers when their patients are prescribed drugs that place them at high risk of developing a potentially lethal cardiac arrhythmia known as torsades de pointes. MedSafety Scan also checks for potentially dangerous drug interactions and suggests options for how to monitor the patient and reduce their risk of harm. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - April 20, 2020 Category: Infectious Diseases Source Type: news

Cardiac Arrhythmia Highlights From ACC 2020 Cardiac Arrhythmia Highlights From ACC 2020
Dr Rachel Lampert of Yale University reviews key studies on cardiac arrhythmia and atrial fibrillation presented at the American College of Cardiology (ACC) 2020 Virtual Conference.Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 16, 2020 Category: Consumer Health News Tags: None ReCAP Source Type: news

Potential Effects of Coronaviruses on the Cardiovascular System
This review highlights that coronavirus disease 2019 is associated with a high inflammatory burden that can induce vascular inflammation, myocarditis, and cardiac arrhythmias, and that CV risk factors should be judiciously controlled per evidence-based guidelines. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - April 2, 2020 Category: Consumer Health News Source Type: news

Ultrasound solves an important clinical problem in diagnosing arrhythmia
(Columbia University School of Engineering and Applied Science) Columbia Engineering researchers have used an ultrasound technique they pioneered a decade ago -- electromechanical wave imaging (EWI) -- to accurately localize atrial and ventricular cardiac arrhythmias in adult patients in a double-blinded clinical study. They evaluated the accuracy of EWI for localization of various arrhythmias in all four chambers of the heart prior to catheter ablation: the results showed that EWI correctly predicted 96% of arrhythmia locations as compared with 71% for 12-lead ECGs. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 25, 2020 Category: International Medicine & Public Health Source Type: news

Johnson & Johnson Launches Heartline ™, the First-of-its-Kind, Virtual Study Designed to Explore if a New iPhone App and Apple Watch Can Help Reduce the Risk of Stroke
New Brunswick, NJ, February 25, 2020 — Johnson & Johnson (NYSE: JNJ) today announced that the Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with Apple, opened enrollment for the Heartline™ Study. The study is designed to explore if the Heartline™ Study app on iPhone and heart health features on Apple Watch can improve health outcomes, including reducing the risk of stroke, with earlier detection of atrial fibrillation (AFib). AFib, a common form of irregular heart rhythm, is a leading cause of stroke in the U.S. To enroll in the Heartline™ Study, individuals must be...
Source: Johnson and Johnson - February 25, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Study reveals how low oxygen levels in the heart predispose people to cardiac arrhythmias
(University of California - Irvine) Low oxygen levels in the heart have long been known to produce life-threatening arrhythmias, even sudden death. Until now, it was not clear how. New findings, in a study led by Steve A. N. Goldstein, MD, PhD, vice chancellor for Health Affairs at the University of California, Irvine, and distinguished professor in the UCI School of Medicine Departments of Pediatrics and Physiology& Biophysics, reveal the underlying mechanism for this dangerous heart disorder. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 18, 2020 Category: International Medicine & Public Health Source Type: news

Abbott Wins Approval for CATALYST Trial for At-Risk Stroke Patients
This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with AFib who are at an increased risk for ischemic stroke." In an email sent to MD+DI, Abbott wrote, “We already have an Amulet IDE trial underway that is intended to support our submission for approval in the U.S. for Amplatzer Amulet. The newly announced CATALYST trial will support our submission for an expanded indication for Amulet as a safe and effective alternative to NOAC drugs for patients with atrial fibrillation and at risk of stroke.”...
Source: MDDI - February 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news

Philips Chooses Healthcare Over Domestic Appliances Unit
Philips is set to shed its domestic appliances unit so it can more effectively focus on its healthcare-related businesses. The company’s CEO Frans Van Houten said the separation could take between the next 12 to 18 months. Philips’ domestic appliances business, which includes kitchen appliances, coffee, garment care, and home care appliances, generated sales of $2.53 billion for 2019. “This [Domestic Appliances] business has significantly contributed to Philips, but it is not a strategic fit for our future, as we choose to further sharpen the focus along the health cont...
Source: MDDI - January 29, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Prolonged breath-holding could help radiotherapy treatment of cardiac arrhythmias
(University of Birmingham) A technique that enables patients suffering from heart conditions to hold their breath safely for over five minutes could have potential as part of a new treatment for cardiac arrhythmias, say researchers at the University of Birmingham. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 20, 2020 Category: International Medicine & Public Health Source Type: news

Antiarrhythmic drug identified as potential treatment for pulmonary arterial hypertension
(Elsevier) High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a potentially fatal disease caused by obstruction of blood flow in the lungs. A new study in The American Journal of Pathology, published by Elsevier, sheds light on the pathology underlying PAH and shows that dofetilide, an FDA-approved KV11.1 channel blocker for the treatment of cardiac arrhythmias (brand name: Tikosyn), may be used for treatment of PAH. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 12, 2019 Category: International Medicine & Public Health Source Type: news

World & #039;s Smallest Reusable Multi-Vital Wearable Sensor Nabs CE Mark
Campbell, CA-based VivaLNK has received Class IIa medical device CE mark for its multi-vital medical wearable sensor and software development kit.  VivaLNK is a Qmed-qualified supplier.   At 7.5 grams, the reusable patch is the smallest of its kind, VivaLNK said. The company also noted that the reusability factor can increase the economic value of using the patch 10-times or more than single-use devices. Also, VivaLNK said the combination of a wearable sensor and an associated software development kit enables any application developer to build medica...
Source: MDDI - December 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Electronics Source Type: news

Marijuana Use Linked to Stroke, Arrhythmia in Young People Marijuana Use Linked to Stroke, Arrhythmia in Young People
Use of marijuana is linked to a higher risk of stroke and hospitalization for cardiac arrhythmia in young people, two new studies suggest.Medscape Medical News (Source: Medscape Psychiatry Headlines)
Source: Medscape Psychiatry Headlines - November 12, 2019 Category: Psychiatry Tags: Neurology & Neurosurgery News Source Type: news

Arrhythmia & EP | Medscape Arrhythmia & EP | Medscape
Review in-depth clinical information, latest medical news, and guidelines about cardiac arrhythmias, including atrial fibrillation, paroxysmal tachycardia, ventricular tachycardia, and ventricular fibrillation. Read about diagnostic tests for arrhythmia and arrhythmia management. (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 11, 2019 Category: Consumer Health News Tags: Resource Center Source Type: news

Stereotaxis, Catheter Precision treat heart arrhythmias
Cardiac arrhythmia patients have been successfully treated for the first time...Read more on AuntMinnie.comRelated Reading: Stereotaxis, Galgo successfully treat cardiac arrhythmias Stereotaxis brings Niobe to Japan Stereotaxis CEO steps down Stereotaxis names new board chair Stereotaxis revenues edge higher in Q4 (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - November 11, 2019 Category: Radiology Source Type: news

Stereotaxis, ADAS 3D successfully treat cardiac arrhythmias
Cardiac arrhythmia patients have been successfully treated for the first time...Read more on AuntMinnie.comRelated Reading: Circle Cardiovascular buys Corstem, inks Galgo deal Stereotaxis brings Niobe to Japan Stereotaxis CEO steps down Stereotaxis names new board chair Stereotaxis revenues edge higher in Q4 (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - November 4, 2019 Category: Radiology Source Type: news

AI Beats Out Clinicians in Triaging Postoperative Patients for ICU
How good is artificial intelligence in decision-making? Not bad according to findings from a pilot study that was recently presented at the American College of Surgeons Clinical Congress 2019. Findings from the study show AI in the form of a machine-learned algorithm correctly triaged the vast majority of postoperative patients to the intensive care unit in its first proof-of-concept application in a university hospital setting. As it stands now surgical teams typically rely on clinical judgment to decide which patients need postoperative intense care because there is no single set of fixed criteria to make the determinati...
Source: MDDI - October 30, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Digital Health Source Type: news

Cardiac arrhythmias and cardiac arrest related to mushroom poisoning: a case report - Li S, Ma QB, Tian C, Ge HX, Liang Y, Guo ZG, Zhang CD, Yao B, Geng JN, Riley F.
BACKGROUND: Mushroom exposure is a global health issue. The manifestations of mushroom poisoning (MP) may vary. Some species have been reported as rhabdomyolytic, hallucinogenic, or gastrointestinal poisons. Critical or even fatal MPs are mostly attributab... (Source: SafetyLit)
Source: SafetyLit - September 21, 2019 Category: International Medicine & Public Health Tags: Home and Consumer Product Safety Source Type: news

FDA clears Biotronik ’ s third-gen injectable cardiac monitor
Biotronik said today that it won 510(k) clearance from the FDA for its Biomonitor III injectable cardiac monitor. Oswego Lake, Ore.-based Biotronik said the Biomonitor III is 60% smaller than its predecessor and offers increased signal quality and a patient app that reports system diagnostics. The device is approved as MR-conditional for both 1.5T and 3.0T scans. “Receiving FDA clearance on Biomonitor III further demonstrates Biotronik’s continued dedication to designing innovative technology solutions that improve patient lives,” president Ryan Walters said in prepared remarks. “This device ma...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Patient Monitoring Regulatory/Compliance Biotronik Source Type: news

UA physician to study sleep apnea and heart health
(University of Arizona Health Sciences) Dr. Salma Patel will explore mortality related to obstructive sleep apnea in individuals suffering from cardiac arrhythmia, with a future focus on alternative therapies to continuous positive airway pressure, or CPAP, devices that help some people sleep better. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - June 5, 2019 Category: International Medicine & Public Health Source Type: news

A review of driving restrictions in patients at risk of syncope and cardiac arrhythmias associated with sudden incapacity: differing global approaches to regulation and risk - Margulescu AD, Anderson MH.
The ability to drive is a highly valued freedom in the developed world. Sudden incapacitation while driving can result in injury or death for the driver and passengers or bystanders. Cardiovascular conditions are a primary cause for sudden incapacitation a... (Source: SafetyLit)
Source: SafetyLit - May 26, 2019 Category: International Medicine & Public Health Tags: Distraction, Fatigue, Chronobiology, Vigilance, Workload Source Type: news

BioSig raises $9m
BioSig Technologies (OTCQB: BSGM) has raised $8.6 million in a new round of equity financing, according to a recently posed SEC filing. The Santa Monica, Calif.-based company is developing the Pure EP system, which is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures. The device is intended to reduce noise and artifacts to produce high-fidelity cardiac signals, which the company claims could increase the diagnostic values of the signals. BioSig is...
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat BioSig Technologies Source Type: news

Novel study links fetal exposure to nicotine and sudden infant death syndrome
(Elsevier) Fetal exposure to tobacco smoke in utero is associated with sudden infant death syndrome (SIDS) and cardiac arrhythmias in newborns. In a novel study in rabbits, investigators provide the first evidence linking fetal exposure to nicotine to long-term alterations of the cardiac sodium current. These changes may impair adaptation of the cardiac sodium current to sympathetic tone and prevent awakening from sleep apnea, leading to arrhythmias that could potentially be involved in SIDS. They report their findings in HeartRhythm (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 28, 2019 Category: International Medicine & Public Health Source Type: news

Boston Scientific touts Luminize catheter study
Boston Scientific (NYSE:BSX) this week touted results from a study of a single-shot ablation catheter for atrial fibrillation at a European cardiac rhythm conference. The Marlborough, Mass.-based medical device giant said the 100-patient AF-ficient I study of intermittent AF proceeded in two stages. Phase one, testing the original Luminize design, showed a pulmonary vein isolation rate of 88.9%; phase two, testing enhanced steering and electrodes, showed a PV isolation rate of 99.4%. The median balloon dwell time dropped from 92 minutes in the first phase to 29 minutes in the second, bringing total procedure time down...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Clinical Trials Featured Boston Scientific Cardiac Rhythm Management Source Type: news

Biotronik wins FDA nod for Acticor, Rivacor high-voltage tachycardia devices
Biotronik said yesterday it won FDA approval for its Acticor and Rivacor high-voltage cardiac rhythm management devices intended for treating patients with cardiac arrhythmias. The clearance covers the Berlin, Germany based company’s Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX devices. “When determining the best treatment plan for each patient, we assess individual needs and select a device system that provides optimal therapy programming with critical diagnostic features. We are often forced to choose between important features, which could compromise opti...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Featured Food & Drug Administration (FDA) Regulatory/Compliance Biotronik Source Type: news

Biotronik Has a New DES Added to its Repertoire
FDA has just signed off on Biotronik’s Orsiro drug-eluting stent (System). The Lake Oswego, OR-based company claims the stent is the first and ultrathin DES to outperform Abbott Laboratories’, Xience stent, which is known as the clinical standard. Biotronik said its first implants will occur this week and that it will be available in health systems in the early part of this year. The company has had CE mark for Orsiro since 2011. Perhaps the biggest selling point of the technology is the ultrathin strut design. “Thinner struts are different in that they potentially crea...
Source: MDDI - February 25, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Risk of cardiac arrhythmias after electrical accident: a single-center study of 480 patients - Pilecky D, Vamos M, Bogyi P, Muk B, Stauder D, Racz H, Nyolczas N, Duray GZ, Zacher G, Zima E.
OBJECTIVE: Patients with electrical injury are considered to be at high risk of cardiac arrhythmias. Due to the small number of studies, there is no widely accepted guideline regarding the risk assessment and management of arrhythmic complications after el... (Source: SafetyLit)
Source: SafetyLit - February 18, 2019 Category: International Medicine & Public Health Tags: Burns, Electricity, Explosions, Fire, Scalds Source Type: news

These medtech companies raised the most VC in 2018
[Image from unsplash.com]Venture capital firms invested more than $2.9 billion in medical device companies in 2018 — a slight increase from the $2.8 billion raised in 2017, according to the MoneyTree report from PricewaterhouseCoopers (PwC) and CB Insights. Both the first and second quarters of 2018 saw an increase in investments, totaling nearly $778 million and $786 million respectively. The third and fourth quarters were slightly lower, with medtech companies raising $738 million in Q3 and nearly $641 million in Q4. There were 218 deals in 2018, a slight decrease from the 229 deals involving me...
Source: Mass Device - February 15, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News venture capital Source Type: news

J & J ’ s Biosense Webster launches IDE-cleared Qdot Micro RF ablation trial
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said yesterday it launched a new FDA investigational device exemption study of its Qdot Micro radiofrequency ablation catheter exploring its use in treating symptomatic drug-refractory paroxysmal atrial fibrillation. The first patient in the trial has already been treated, with the procedure taking place at NYU Langone Health’s Heart Rhythm Center, the Irvine, Calif.-based J&J division said. “The delivery of 90 watts of RF power in a short, four-second ablation session is a significant advancement in the treatment of paroxysmal atrial fibri...
Source: Mass Device - February 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Food & Drug Administration (FDA) johnsonandjohnson Source Type: news

Prolonged QT syndrome due to donepezil: a reversible cause of falls? - Jackson EG, Stowe S.
We report a case of prolonged QT syndrome caused by donepezil which resulted in a fall and hip fracture. In this case... (Source: SafetyLit)
Source: SafetyLit - January 21, 2019 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

iRhythm Finds Its Groove at the Intersection of Cardiology and AI
iRhythm Technologies has the distinct feature of being at the intersection of some of the hottest markets in medtech – cardiology, wearables, and artificial intelligence. The San Francisco-based company has developed, the Zio Patch XT, a wearable technology to monitor heart rate activity for up to 14 days and is set to present at the 37th Annual J.P. Morgan Healthcare Conference this week. Tim King, iRhythm’s president and CEO spoke to MD+DI ahead of the company’s presentation about the company's success and its goals going forward. “The tool of choice...
Source: MDDI - January 8, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Digital Health Source Type: news

New study shows link between secondhand smoke and cardiac arrhythmia
(University of California - Davis Health) Continuous indoor exposure to secondhand tobacco smoke triggers changes in the heart's electrical activity, known as cardiac alternans, that can predict cardiac arrhythmia and sudden cardiac death, a new study from UC Davis Health researchers shows. The authors believe the study, conducted in mice, suggests that secondhand smoke exposure alters cells that regulate how the heart beats. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 26, 2018 Category: International Medicine & Public Health Source Type: news

Cardiva Medical wins FDA PMA for Vascade MVP vascular closure device
Cardiva Medical said today it won FDA premarket approval for its Vascade MVP venous vascular closure device. The Vascade MVP system is composed of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc, the Santa Clara, Calif.-based company said. The device functions by placing a collapsible mesh disc against the inner vessel wall to stop bleeding followed by a collagen patch and the removal of the mesh disc, the company said. The collagen patch is designed to expand, seal and stop bleeding and is later absorbed by the body. Cardiva touted the Vascade MVP as the first and only vascular closure system ...
Source: Mass Device - December 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Vascular Cardiva Medical Inc. Source Type: news

J & J ’ s Biosense Webster launches Heliostar multi-electrode ablation cath trial
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said this week that it enrolled and treated the first patient in its Stellar U.S. investigational device exemption study. The 640-patient trial is designed to assess the safety and efficacy of the Heliostar multi-electrode radiofrequency balloon ablation catheter as a treatment for drug refractory recurrent paroxysmal atrial fibrillation. The Heliostar device features 10 electrodes and is designed to allow electrophysiologists to achieve pulmonary vein isolation with a single application of RF energy, according to Biosense Webster. Cardiac electrophysiologists Drs. ...
Source: Mass Device - November 30, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Catheters Clinical Trials Featured Wall Street Beat Biosense Webster johnsonandjohnson Source Type: news

J & amp;J Subsidiary Launches IDE Study for AF
A new U.S. study aims to evaluate a radiofrequency (RF) balloon ablation catheter for the treatment of symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation. Biosense Webster, a subsidiary of Johnson & Johnson, said the investigational device exemption study will enroll up to 640 patients at as many as 40 clinical sites worldwide. The STELLAR study will evaluate the company's Heliostar RF balloon ablation catheter. "This new balloon catheter is unique because it conforms to any pulmonary vein anatomy and allows me to control electrodes individually ...
Source: MDDI - November 29, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

BioSig inks Pure EP first-in-human study deal with Texas Cardiac Arrhythmia Institute
BioSig Technologies (OTCQB: BSGM) said today that it inked a deal with Austin’s Texas Cardiac Arrhythmia Institute at St. David’s Medical Center to launch first-in-human studies using its Pure EP system. The Santa Monica, Calif.-based company’s Pure EP system is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures. The device is intended to reduce noise and artifacts to produce high-fidelity cardiac signals, which the company claims...
Source: Mass Device - November 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Clinical Trials BioSig Technologies Source Type: news

Abbott Initiates Study to Evaluate Ablation as a Frontline Treatment for Patient's Suffering from a Common but Complex Cardiac Arrhythmia
LESS-VT Study is the first U.S. clinical trial to evaluate the safety and effectiveness of ablation treatment for patients with monomorphic ventricular tachycardia, a common heart rhythm disorder (Source: Abbott.com)
Source: Abbott.com - November 20, 2018 Category: Pharmaceuticals Source Type: news

The association between unexplained falls and cardiac arrhythmias: a scoping literature review - Wiseman T, Betihavas V.
BACKGROUND: Falls in older adults are common. Age is a risk factor for falls and with an ageing population, presentation to the emergency department (ED) resulting from falls is rising. Reasons for falls in older adults are numerous and include cardiac arr... (Source: SafetyLit)
Source: SafetyLit - November 16, 2018 Category: International Medicine & Public Health Tags: Age: Elder Adults Source Type: news

Cardiva touts results from pivotal Vascade MVP vascular closure device trial
Cardiva Medical today released results from the pivotal study of its Vascade MVP vascular closure device intended for multi-access venous closure following electrophysiology procedures, touting that the trial met its primary and secondary endpoints. The results from the AMBULATE trial were presented today at the American Heart Association’s annual Scientific Sessions by Texas Cardiac Arrhythmia Institute exec medical director Dr. Andrea Natale. The Vascade system is composed of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc, the Santa Clara, Calif.-based company said. The device fun...
Source: Mass Device - November 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Cardiva Medical Inc. Source Type: news

Preventing sudden cardiac death with genome editing
(Baylor College of Medicine) Gene editing successfully prevented sudden cardiac death in a mouse model of inherited cardiac arrhythmia disorder. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - October 30, 2018 Category: Biology Source Type: news

FDA approves Abbott ’ s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure. With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant. “We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev technology—takes an established innovation and improves upon it in meaningful ways to help people with...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news

Pins and needles: How acupuncture can help soothe an irregular heartbeat
(Natural News) Cardiac arrhythmia describes an irregular heartbeat caused by an interruption of electrical impulses in heart function. This group of conditions can be further broken down into bradycardia (slow heartbeat), tachycardia (fast heartbeat), flutter or fibrillation (irregular heartbeat), or premature contraction (early heartbeat). While most types of heart arrhythmia are relatively harmless (caused by... (Source: NaturalNews.com)
Source: NaturalNews.com - October 6, 2018 Category: Consumer Health News Source Type: news

Judge pares claims in Bard IVC bellwether
A federal judge in Arizona yesterday pared some claims in the third bellwether case involving inferior vena cava filters made by Becton Dickinson (NYSE:BDX) subsidiary C.R. Bard, as the trial entered its 11th day. It’s the fourth bellwether in the multi-district litigation over the IVC devices, which are designed to prevent blood clots from passing through the body’s largest vein into the heart and lungs. In the first case to go to trial, a federal jury in Phoenix found for plaintiff Sherr-Una Booker, awarding $3.6 million in damages. Bard prevailed in the second bellwether trial, with the jury findin...
Source: Mass Device - October 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Product Liability Vascular bectondickinson crbard Source Type: news