Press Releases

BIOTRONIK, a leading manufacturer of cardiovascular medical devices, today announced the completion of patient enrollment in the superficial femoral artery (SFA) arm of its BIOFLEX-I clinical trial, an FDA-approved investigative device exemption (IDE) trial evaluating the use of self-expanding nitinol stents in treating peripheral artery disease. A total of 296 patients were successfully implanted with the Astron Pulsar and Pulsar-18 stents at 34 centers in the US, Canada and Europe. 

An innovative National Drug Early Warning System is being developed to monitor emerging trends that will help health experts respond quickly to potential outbreaks of illicit drugs such as heroin and to identify increased use of designer synthetic compounds. The system will scan social media and Web platforms to identify new trends as well as use conventional national- and local-level data resources.

Due to rapidly increasing demand for its cardiac cath lab PCI, Diagnostic and Carotid Stenting accreditation and quality review services, ACE is proud to lead the way in offering four new accreditation and external review services for catheter based cardiovascular procedures to include: Congenital Heart Disease, Electrophysiology including Implants & Devices, Transcatheter Valve Therapies and Peripheral Vascular Procedures.

Bristol-Myers Squibb Company and Pfizer Inc.  today announced that the first patient has been enrolled into a Phase IV clinical trial called EMANATE (Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with NVAF) assessing the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation (NVAF) undergoing cardioversion.

Boston Scientific Corporation (NYSE: BSX) has received CE Mark and begun the European commercial launch of its new 25 mm Lotus Transcatheter Aortic Valve Implantation (TAVI) System, complementing the currently available 23 mm and 27 mm valve sizes.

BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced the first implantations worldwide of its new ICD and CRT-D series (implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators). With Sentus quadripolar leads and the Inventra series, BIOTRONIK offers the only devices for patients with heart failure worldwide that are approved for MRI use. The quadripolar Sentus lead eases the implantation process by giving physicians access to challenging vessels. With CE approval in early July, BIOTRONIK's new implantable defibrillator series includes the industry’s first quadripolar left-ventricular leads to be approved for MRI use. 

Following a heart attack, many heart failure patients suffer from enlargement of their left ventricle, diminishing the amount of blood the heart can pump to the body and resulting in life-threatening left-sided heart failure symptoms such as shortness of breath, decreased urine production, fatigue, and irregular or rapid heartbeat. Treatment options for patients whose left ventricle has enlarged have been limited, until now. Through a percutaneous (needle-puncture of the skin) procedure now available through a clinical trial at PinnacleHealth CardioVascular Institute the first minimally invasive catheter-based device aims to restore normal geometry and function in the damaged muscle (left ventricle). The device is called Parachute and is created by CardioKinetix in California.

Demonstrating its continued leadership in the development of innovative solutions for peripheral vascular disease, Boston Scientific Corporationhas received CE Mark for the Ranger Paclitaxel-Coated PTA Balloon Catheter. 

480 Biomedical, Inc. today announced that it has been awarded Phase II funding from the National Heart, Lung, and Blood Institute (NHLBI) to continue the development of a bioresorbable, self-expanding scaffold to treat pediatric pulmonary artery stenosis.

Frank F. Ing, MD, FAAP, FACC, FSCAI, associate chief of Cardiology and director of the Cardiac Catheterization Laboratory at Children’s Hospital Los Angeles, has taken on two new roles at CHLA: chief of the Division of Cardiology and co-director of the Heart Institute. Ing replaces Michael Silka, MD, who filled both positions for more than 15 years. Ing assumed his new responsibilities as of July 1.

AstraZeneca today announced an agreement with the Max Planck Institute of Molecular Physiology (MPI), Germany, to establish a ‘satellite unit’ in cardiovascular and metabolic disease (CVMD), linked to AstraZeneca’s CVMD Innovative Medicines unit (iMed) in Mölndal, Sweden, to study new modalities chemistry.

Thomas Wakefield, M.D., has been appointed a director of the University of Michigan Frankel Cardiovascular Center, as James C. Stanley, M.D., resumes his role as professor of vascular surgery and associate chair of the U-M Department of Surgery.

Today, Texas Children's Heart Center is excited to announce the addition of two new members to its Adult Congenital Heart Disease Program team: pediatric and adult cardiologist, Dr. Peter Ermis, and pediatric and adult cardiologist, Dr. Wilson Lam. Texas Children's Heart Center is ranked #2 nationally in cardiology and heart surgery by U.S. News & World Report. For more information about the Adult Congenital Heart Disease Program at Texas Children's Hospital, visit the website.

Mount Sinai Heart at Icahn School of Medicine at Mount Sinai has created an innovative Center for Medical Devices (CMeD) to advance the field of cardiovascular medicine and accelerate the delivery of promising medical devices to cardiac patients. Julie Swain, MD, an experienced cardiothoracic surgeon and medical device expert has been recruited by Mount Sinai to help lead this pioneering initiative.

LipoScience, Inc. today announced the publication of the first large-scale real world study evidencing a link between low LDL-P and reduced cardiovascular disease (CVD) risk.  Data in the study published in Atherosclerosis demonstrated that high-risk patients who achieved a low LDL-P level experienced a 22-25 percent reduction in CVD risk compared to high-risk patients that achieved a low LDL-C level.

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to idarucizumab, an investigational fully humanized antibody fragment, or Fab, being studied as a specific antidote for Pradaxa (dabigatran etexilate mesylate).

All Children’s Hospital pediatric cardiovascular surgeon Jeffrey Jacobs, M.D., led a team of 60 physicians, nurses and other healthcare professionals from throughout the United States and world on a special medical mission to Kingston, Jamaica to treat children for a variety of cardiac related medical conditions.

The American Heart Association presented its 2014 Gold Heart Award to Baltimore executive Neil Meltzer, M.P.H., and Chicago cardiologist Clyde Yancy, M.D., M.Sc. The award is the highest honor the association gives in recognition of continued, distinguished service.

Neil J. Stone, MD, a Northwestern Medicine cardiologist for more than four decades, was named the American Heart Association's 2014 Physician of the Year, the organization's honor given annually to a physician who has rendered "outstanding accomplishments."

EKOS Corporation, a BTG International group company, today announces the start of patient enrollment for the ACCelerated ThrombolySiS for Post-Thrombotic Syndrome using the EKOS System (ACCESS PTS) Study.

Moving toward U.S. market introduction of its novel medical device to treat peripheral artery disease, Medtronic, Inc. (NYSE: MDT) today announced that it recently submitted the final module of its pre-market approval (PMA) application for the IN.PACT Admiral drug-coated balloon to the U.S. Food and Drug Administration (FDA). The application includes data that demonstrates superior clinical outcomes compared with conventional angioplasty, with the lowest rates of repeat procedures (target lesion revascularization) and the highest rate of uninterrupted blood flow (primary patency) at 12 months ever reported for the interventional treatment of peripheral artery disease.