Press Releases

Preventice, developer of the PatientCare Platform and the BodyGuardian Remote Monitoring Sensor and an innovator in software solutions for remote patient care, and eCardio Diagnostics LLC, a leading provider of remote cardiac monitoring products and services, announced today a strategic combination of Preventice and eCardio to drive innovation and growth in remote monitoring systems and mobile health applications. The two companies will now operate as wholly-owned subsidiaries of a newly formed holding company, Preventice, Inc.

Symetis SA, the leading European developer of transcatheter aortic valve implantation (TAVI) systems, announced today the launch of ACURATE neo, its 15F compatible transfemoral TAVI system. Commercial implantations started early September after Symetis received CE Mark approval for ACURATE neo this summer.

Codman Neuro, part of DePuy Synthes Companies of Johnson & Johnson, announced regulatory approval from the China Food and Drug Administration (CFDA), South Korea’s Ministry of Food and Drug Safety (MFDS), and the Taiwan Food and Drug Administration (TFDA) for the company’s REVIVE SE Thrombectomy Device, a next-generation self-expanding clot removal device intended to restore blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease.

Claret Medical, Inc., developer of innovative solutions for cerebral protection during structural heart, vascular and cardiac surgery procedures, today announced completion of enrollment in the CLEAN-TAVI clinical trial studying its filter-based cerebral protection system (CPS). The trial was designed as a first-of-its-kind, randomized controlled trial powered to definitively demonstrate the importance of cerebral protection in reducing the number and volume of new cerebral lesions created by debris lodged in the brain as a result of transcatheter aortic valve implantation (TAVI).

Medtronic, Inc. today announced CE (Conformité Européene) Mark for the 23 mm CoreValve Evolut(TM) R System for transcatheter aortic valve implantation (TAVI). The novel, self-expanding valve and 14FR equivalent delivery system offers new capabilities that  advance valve performance and deliverability during the procedure, while providing the option to recapture (re-sheath the valve back into the catheter) and reposition (move the valve to a new position either above or below its current placement) the valve during deployment phase, if needed.

Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from a new post-hoc sub-analysis of the pivotal phase III RE-LY trial assessing renal function change in patients with non-valvular atrial fibrillation (NVAF) treated with Pradaxa (dabigatran etexilate mesylate) compared to warfarin. The findings suggest that patients treated with PRADAXA experienced a slower decline in kidney function compared to those being treated with warfarin, with the slower decline most marked in patients treated with PRADAXA who had mild kidney impairment at the start of the RE-LY trial. The results were presented today during the European Society of Cardiology (ESC) Congress 2014.

Daiichi Sankyo and the Heart Rhythm Society today announced results from a global survey, which polled cardiologists from around the world and revealed that a majority (58%) of cardiologists agree that there is no such thing as a “typical” non-valvular atrial fibrillation (NVAF) patient.

Daiichi Sankyo Company, Limited today announced data from a subgroup analysis of the phase 3 ENGAGE AF-TIMI 48 study, that explores the relationship between edoxaban dose, concentration and anti-factor Xa activity in patients with non-valvular atrial fibrillation (NVAF). The analysis also compared rates of major bleeding and efficacy outcomes [stroke and systemic embolic events (SEE)] of edoxaban versus warfarin, stratified by dose reduction status.

The American College of Cardiology is looking for six inspiring individuals who are living well with heart disease to be featured on its patient-focused website CardioSmart.

Experts discussed the benefits of Home Monitoring technology from the perspective of patients, hospitals and payers for the first time at a press conference held by BIOTRONIK at the European Society of Cardiology's annual congress, ESC Congress 2014.

Direct Flow Medical, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced it has received the CE Mark (Conformité Européenne) for a 23mm sized valve as part of its Direct Flow Medical Transcatheter Aortic Valve System, expanding the patient population that can be treated with its technology. The company also announced receipt of the CE Mark for implantation of all of its valves without the use of contrast media, protecting patients from kidney injury during transcatheter aortic valve implantation (TAVI).

AliveCor, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its algorithm to detect atrial fibrillation (AFib), the most common form of cardiac arrhythmia. 

Royal Philips today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its precision planning application for Transcatheter Aortic-Valve Implantation (TAVI) treatments. Through 3D imaging, the Philips TAVI application provides interventionalists with pre-procedural, high-precision positioning to treat aortic stenosis ailments.   

Boston Scientific Corporation and ASAHI INTECC have formalized plans to develop a new, differentiated fractional flow reserve (FFR) wire.  The joint project focuses on creating a device intended to improve handling compared to existing FFR wires.

Cook Medical has enrolled the first patient in the clinical study in China of its Zilver PTX Drug Eluting Peripheral Stent. The case was performed by one of the study’s principal investigators, Prof. Peng Liu, M.D., at the China-Japan Friendship Hospital in Beijing.

GE Healthcare introduces the Vscan with Dual Probe with the first of its kind 2-in-1 probe to give healthcare providers more uses for pocket ultrasound. This powerful pocket-sized ultrasound tool houses two transducers in a single probe, allowing clinicians to see both shallow and deep views of the body without changing probes. This latest innovation enables efficient triage and fast workflow, which may lead to time and cost savings in many point of care settings.

Framingham, Mass., August 4, 2014 – HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced the appointment of Katrin Leadley, M.D., as Chief Medical Officer of HeartWare, effective September 1, 2014. 

University of Houston (UH) professor Suncica "Sunny" Canic is a mathematician, not a medical doctor, but her research could save the lives of heart patients. Working with collaborators from Houston Methodist Hospital on a minimally invasive experimental procedure for heart valve replacement, Canic's work could lead to optimal design of an alternative to open-heart surgery for treating failing heart valves.

The exceptions committee from the Commonwealth of Pennsylvania has announced its approval of the UPMC East application to perform elective PCI without onsite open heart surgery for their cardiac catheterization lab. The decision by the Commonwealth to provide the exception was based, in part, on UPMC East's successful application for accreditation by ACE.

Regenerative medicine experts at the Cedars-Sinai Heart Institute have opened a new clinic to evaluate heart and vascular disease patients for participation in stem cell medical studies.

Providing hospitals with resources and support to develop and improve patient care programs, AHRA: The Association for Medical Imaging Management announces the seventh year of its Putting Patients First Program. Putting Patients First grants enable healthcare facilities to fund programs, training or seminars aimed at improving patient care and safety and customizing treatment in CT, MR, Ultrasound, X-ray and Vascular imaging. The grants are funded by an unrestricted educational grant from Toshiba America Medical Systems, Inc.