St. Jude Medical, Inc., a global medical device company, today announced that the Center for Medicare and Medicaid Services (CMS) has approved a New Technology Add-on Payment (NTAP) for the CardioMEMS HF System. The CardioMEMS HF System is the first and only U.S. Food and Drug Administration approved heart failure (HF) monitoring device that has been proven to significantly reduce hospital admissions when used by physicians to manage heart failure. The NTAP program, which recognizes new technologies that provide substantial clinical improvement over already available therapies, is designed to support timely access to innovative technologies for Medicare beneficiaries.

Cardioxyl Pharmaceuticals, Inc. announced today the positive results of a clinical trial demonstrating that CXL-1427, a novel potential treatment for acute decompensated heart failure (ADHF), was well tolerated in healthy volunteers. The company has now initiated dosing of hospitalized patients with decompensated heart failure in a Phase IIa clinical trial designed to further evaluate the drug’s safety and tolerability as well as its dosing levels.

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.

Privately-held ReliantHeart, a leading innovator in mechanical circulatory support therapies, today announced the first advanced stage heart failure patient received its next generation HeartAssist5 Ventricular Assist Device (VAD) since the company earned CE Mark approval for design enhancements just weeks ago.  Cardiologists at the Deutsches Herzzentrum Berlin (DHZB - German Heart Institute) in Germany performed the life-saving procedure.

Innovative treatments for heart failure are lacking, leaving the nearly six million Americans who suffer from the condition with little hope for a cure. But thanks to an $11.5-million Program Project Grant (PPG) from the National Heart, Lung, and Blood Institute (NHLBI), scientists at Temple University School of Medicine are now set to further their investigation of key molecular mechanisms in heart failure, an effort that is expected to lead to the development of new heart therapies.

Abiomed, Inc., a leading provider of breakthrough heart support technologies, today announced it has received approval for implementation of a Continuous Access Protocol (CAP) from the Food & Drug Administration (FDA) for RECOVER RIGHT, an Investigational Device Exemption (IDE) study of the Impella(R) RP (Right Peripheral) System.

On April 17, 2014, SynCardia Systems, Inc. received the CE Mark for the SynCardia temporary Total Artificial Heart with SynHall valves, providing the company with control over the last key component required for heart manufacturing.