News

Medtronic, SYMPLICITY, SYMPLICITY HTN-3 trial, renal denervation, ACC.14

A major disappointment earlier this year was the announcement by Medtronic that its renal denervation system failed to meet its primary endpoint for efficacy in the U.S. SYMPLICITY HTN-3 trial....

CBSET Renal Denervation Hypertension Therapies Symplicity-3 Trial

Scientists at CBSET are reminding thought leaders in renal denervation that there is a seminal experimental and computational template for the more rational, comprehensive preclinical evaluation...

ReCor Medical Paradise System Renal Denervation RDN Therapy Hypertension

ReCor Medical advanced its Paradise System for renal denervation (RDN) for treatment resistant ...

SHEA Infection Control General Cardiology CT Systems White Coats

The Society for Healthcare Epidemiology of America (SHEA), an infection control organization, issued voluntary...

FDA Premarket Approval PMA Clinical Study EP Lab Cath Leads Implantable Devices

The U.S. Food and Drug Administration (FDA) has approved many cardiac implantable electronic device...

hypertension therapies cvrx barostim neo therapy

CVRx Inc. announced findings from a health-economic analysis published in the Journal of Hypertension that indicates Barostim Therapy is a cost-effective treatment option for...

Medtronic, symplicity, renal denervation

Medtronic Inc. announced its U.S. pivotal trial for its Symplicity renal denervation system to treat resistant hypertension, the SYMPLICITY HTN-3 trial, failed to meet its primary efficacy...

medtronic symplicity renal denervation therapy hypertension cath lab trial study

Medtronic Inc. announced that the first patients were randomized in Symplicity HTN-4, which will evaluate the Symplicity ...

medtronic symplicity spyral renal denervation cath lab hypertension treatment G3

Medtronic Inc. announced CE mark in Europe and Therapeutic Goods Administration (TGA) listing in Australia for its flexible 4 French multi-electrode Symplicity Spyral ...

Medtronic, Inc. presented three-year data from SYMPLICITY HTN-2, the first and longest-running randomized, controlled clinical trial of renal denervation, which continue to demonstrate results...

The 2014 Top 10 Health Technology Hazards list raises awareness of the potential dangers associated with the use of medical devices and helps healthcare providers minimize the risk of technology-...

renal stenting

The use of renal stenting in combination with medication-based therapy to treat hypertension showed no improvement in patient outcomes over the use of medications alone in treating hypertension....

Petr Neuzil, M.D., Nemocnice Na Homolce Hospital, Prague, Czech Republic, presented three-month results from the WAVE II study and complete six-month results for the WAVE I (first-in-man) at the...

renal denervation clinical trial study hypertension cath medtronic symplicity

Medtronic Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE), allowing the company to initiate SYMPLICITY HTN-4, the first...

blood pressure monitors stroke treatment devices hypertenion therapies cath lab

A new way of using blood pressure-lowering medications could prevent more than a fourth of heart attacks and ...

Medtronic Inc. announced U.S. Food and Drug Administration (FDA) approval of its Lead Integrity Alert (LIA) software for use with non-Medtronic ...

renal denervation clinical trial study hypertension vessix boston scientific

Patients treated with the Boston Scientific Vessix Renal Denervation System experienced a significant and...

renal denervation therapy hypertension kona medical morningside

Kona Medical Inc. announced it has closed a Series D equity financing of $10 million. Morningside Group, a broad-based investment firm with significant presence in China, led the investment and is...

renal denervation, Symplicity

Since its debut in 2010, the renal denervation market has generated enthusiasm across the medical device...

cath lab cardiovascular surgery clinical trial/study scai heart attack

The Society for Cardiovascular Angiography and Interventions (SCAI) assembled  a panel that has proposed new criteria for identifying patients who experience a heart attack after coronary...

Rox Medical has crossed the halfway point in the CONTROL-HTN international, multi-center, randomized controlled hypertension trial. The milestone was met with the enrollment of the first patient...

A new study of patients who died of sudden cardiac arrest, a usually fatal condition that causes the heart to stop beating, shows the majority who qualified to receive potentially lifesaving...

Among patients with prehypertension and coronary artery disease, use of the renin (an enzyme secreted by the kidneys) inhibitor aliskiren, compared with placebo, did not result in improvement or...

September 3, 2013 — St. Jude Medical Inc. announced the CE mark approval of its next-generation EnligHTN renal denervation system for treating patients with drug-resistant, uncontrolled...

Qinghui Chen, assistant professor in Michigan Tech’s kinesiology and integrative physiology department, wants to get to the bottom of two cardiovascular diseases: hypertension and congestive heart...

Tyrx AIGISRx R Fully Resorbable Antibacterial Envelope Implantation

The first implantation of Tyrx Inc.’s new AigisRx R Fully Resorbable Antibacterial Envelope has taken place at the Vanderbilt Heart and Vascular Institute in Nashville, Tenn., by Christopher R....

Mercator MedSystems has been issued U.S. Patent 8,465,752, which protects the company’s sole U.S. rights to deliver drugs or other nerve modifying agents to tissue surrounding arteries for...

MEDTRONIC, symplicity renal denervation catheter

One of the exciting new frontiers for interventional cardiology is the use of renal denervation therapy to treat pharmacologically uncontrolled hypertension. It is estimated there are more...

July 18, 2013 — In a study of more than 2,000 adults, researchers found that two MRI (magnetic resonance imaging) measurements of the abdominal aorta — the amount of plaque in the vessel and the...

St. Jude Medical Inc. announced U.S. Food and Drug Administration (FDA) approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN Multi-Electrode Renal...

Boston Scientific Vessix Renal Denervation System Hypertension Therapies

Boston Scientific Corporation reported interim data from the REDUCE-HTN clinical program, which demonstrated a significant and sustained reduction in the blood pressure of patients treated with...

June 3, 2013 — St. Jude Medical Inc. announced the company’s EnligHTN multi-electrode renal denervation system provides a safe, rapid and sustained reduction in blood pressure...

Kona Medical announced three and six month results from the WAVE I study, a first-in-man study evaluating the safety and efficacy of Kona Medical’s Surround Sound Renal Denervation System for...

Can high blood pressure be safely reduced and controlled by “disconnecting” nerves in the kidneys? That is a question that a new ...

Prof. Dr. Béla Merkely and Dr. Péter Sótonyi at Semmelweis Egyetem Kardiológiai Központ in Hungary completed the first patient implant of the Barostim neo device for...

The incremental mortality in implantable pacemaker and defibrillator recipients who experience a device infection, compared to patients without device infection, is substantial and persists for at...

Wearable cardioverter defibrillators (WCD) can be an effective therapy option for patients with a transient or undefined arrhythmic risk, according to the WEARIT-II Registry, the largest...

Cardiosonic Inc. announced the completion of the first phase of patient enrollment in its first-in-man (FIM) TIVUS I clinical study. The study is designed to collect data on the safety and...

AigisRX Antibacterial Envelope Tryx Infection Control

 

Tyrx announced the first implantation of its new AigisRx R Fully Resorbable Antibacterial Envelope has taken place at the Quebec Heart and Lung Institute in Quebec City, Canada by Dr...

A research study of more than 600 black patients with uncontrolled hypertension found that less than half were prescribed a diuretic drug with proven benefit that costs just pennies a day, report...

Tyrx Inc. has received a license from Health Canada to market its new AigisRx R Fully Resorbable Antibacterial Envelope technology with implantable electronic devices (IEDs). The AigisRx R...

Rox Medical announced enrollment of the first U.K. patients in the CONTROL-HTN international randomized controlled trial of the Rox Flow procedure for the treatment of resistant hypertension.

Using a telemedicine system to engage people in underserved, urban communities to measure and report their blood pressure remotely — outside of the doctor’s office — appears to help them achieve...

Symplicity Renal Denervation System Medtronic Inc. Parallel Review Program

Medtronic Inc. announced the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have accepted the inclusion of the Symplicity renal denervation system...

Zoll wearable defibrillator

Oklahoma Heart Hospital (OHH), Oklahoma’s first dedicated heart hospital, has excelled at creating quality outcomes through an integrated approach to patient care. To maintain this culture of...

Researchers at The Johns Hopkins University and Yale University have discovered that a specialized receptor, normally found in the nose, is also in blood vessels throughout the body, sensing small...

Renal Denervation Clinical Study EnligHTNment Trial St. Jude Medical

St. Jude Medical Inc. announced plans for a new landmark study that will evaluate whether renal denervation and medication can provide health benefits to patients beyond lowering high blood...

Sunshine act, disclosure, cardiology, radiology

The White House’s recent approval of the Physician Payment Sunshine Act mandates transparency within physician-industry relationships. Data recording begins Aug. 1, 2013, so it is necessary for...

St. Jude Medical EnligHTN II trial Renal Denervation System

St. Jude Medical Inc. announced enrollment of the first patient in the EnligHTN II trial. This post-market clinical study will further evaluate the safety and efficacy of the EnligHTN renal...

St. Jude Medical has issued a Class I recall for its Amplatzer TorqVue FX Delivery System used in transcatheter closure of atrial septal defects (ASDs). The company said in a small number of cases...

Covidien began the commercial launch of the OneShot Renal Denervation System, an over the wire balloon-based irrigated ablation catheter technology for the treatment of hypertension...

August 20, 2012 — Zoll Medical Corp., a manufacturer of medical devices and related software solutions, announced that physicians at all of the 17 “Honor Roll” hospitals and all of the 50 “Best...

December 27, 2012 — Cardiosonic Inc., a private developer of technology in the field of renal denervation for the treatment of hypertension, announced it has closed on the first $6.1 million of a...

RealView's 3-D holographic projection of a heart

The annual Transcatheter Cardiovascular Therapeutics (TCT) meeting brings many cutting-edge technologies to the forefront during its five days of clinical sessions. This is my editor’s choice of...

December 20, 2012 — BlipCare has presented the world's first Wi-Fi blood pressure monitor on international crowd funding site Indiegogo.

Hospitalized children who suffer cardiac arrest are nearly three times more likely to survive than they were about a decade ago, and no more likely to suffer brain impairment, according to new...

St. Jude Medical EnligHTN Renal Denervation System

St. Jude Medical Inc. announced that the company’s EnligHTN renal denervation system provides a safe, effective and sustained reduction in office and ambulatory blood pressure measurements at six...

More than 350,000 deaths occur each year as a result of sudden cardiac arrest (SCA), which occurs when the heart abruptly and unexpectedly stops beating. A survey issued by the Heart Rhythm...

Boston Scientific Renal Denervation Vessix Vascular

November 8, 2012 — Boston Scientific Corp. is extending its reach into the renal denervation market by signing a...

November 7, 2012 — Kona Medical Inc. announced the initiation of the first clinical study of its device...

Paradise System ReCor Medical Hypertension Therapies Renal Denervation

November 5, 2012 — ReCor Medical reported one-year follow-up data on patients who have been treated via renal denervation...

Tyrex AigisRx Antibacterial Envelope EP Lab Pacemakes ICD

TyRx Inc. announced that it has received a license from Health Canada to market its AigisRx Antibacterial Envelope. The AigisRx Envelope is specifically designed to stabilize...

October 3, 2012 — Royal Philips Electronics announced it is donating the one-millionth HeartStart automated external defibrillator (AED) manufactured to Everett Mountain Rescue Unit (EMRU) of...

October 3, 2012 — Sharp Memorial Hospital was the first on the West Coast to participate in Medtronic's SYMPLICITY HTN-3 clinical trial in March, and is currently the leading trial site in ...

August 21, 2012 — Zoll Medical Corp. entered into an agreement to license Inovise Medical Inc.’s ambulatory Audicor technology as part of the advanced patient diagnostics in the LifeVest...

August 15, 2012 — Sound Interventions Inc. has released three-month data from the company's first-in-human clinical study (SOUND-ITV) to...

August 3, 2012 — In a bid to help control healthcare costs, on Oct 1, 2012, the Centers for Medicare and Medicaid Services (CMS) will stop paying hospitals for treating potentially avoidable...

Access site complications, hemostasis management, vascular closure

Percutaneous coronary interventional (PCI) procedures are performed throughout hundreds of US institutions every day. With the increasing frequency of these procedures being performed comes an...

June 1, 2012 — Kona Medical Inc. announced it has raised $30 million in Series C financing to advance its novel hypertension therapy. Existing investors Essex Woodlands, Domain Associates,...

May 18, 2012 -- St. Jude Medical Inc., a global medical device company, announced that preliminary data demonstrated the company’s EnligHTN renal denervation system was safe and effective for the...

May 15, 2012 – St. Jude Medical Inc., a global medical device company, announced CE mark approval and launch of its EnligHTN renal denervation system during EuroPCR. Renal denervation is a...

May 9, 2012 — Sound Interventions Inc. announced the successful completion of the company's first-in-human clinical trial to treat resistant hypertension, SOUND-ITV.

May 4, 2012 - Medtronic Inc. announced six-month pooled outcomes from randomized and crossover patients in the Symplicity HTN-2 clinical trial following renal denervation with the Symplicity renal...

May 2, 2012 — Vessix Vascular Inc. announced this week that it has received CE mark approval for its V2 Renal Denervation System for the treatment of hypertension. Renal denervation is a...

ReCor Medical disclosed updated data for the REDUCE First-In-Man clinical study of its CE-marked Paradise (percutaneous renal denervation system) ultrasound platform, which is...