Patient enrollment has been initiated in a post-market registry for the COMBO Dual Therapy Stent to evaluate its long-term safety and performance in routine clinical practice. The prospective, multicenter, all-comers REMEDEE Registry (Multicenter, Prospective, Clinical Outcomes After Deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) Post Market Registry) will enroll 1,000 patients at nine European sites. More than 100 patients have already been enrolled.

JenaValve Technology, Inc. announced that it has raised $62.5 million in a Series C venture round.

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 from Prof. Markus van der Giet and Prof. Walter Zidek of the Charite Hospital, Benjamin Franklin Campus, Berlin. The CONTROL-HTN trial is evaluating the Rox Flow procedure — creating a small connection between artery and vein in the upper leg - for the treatment of resistant hypertension.

Parker Laboratories is introducing three, completely redesigned Thermasonic Gel Warmers at RSNA 2013. These include a single bottle gel warmer, a three-bottle gel warmer with preset temperature options and LED indicators, and a three-bottle gel warmer with LCD readout and temperature adjustment in one degree increments, in either Fahrenheit or Celsius.

FDA regulates apps, mobile devices

In an effort to guide regulation of mobile medical apps, the U.S. Food and Drug Administration (FDA) issued a final guidance document for developers of mobile medical apps. 
Medicare Expenses Growth Heart Attack Patients 1998 2008

Medicare expenses for patients with acute myocardial infarction (AMI, heart attack) increased substantially between 1998 and 2008, with much of the increase coming in expenses 31 days or more after the patient was hospitalized, according to a study published by JAMA Internal Medicine, a JAMA Network publication.
Icahn School of Medicine at Mount Sinai PARIS Study Antiplatelet Therapy PCI

Lead study investigators from Icahn School of Medicine at Mount Sinai presented their Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients (PARIS) study findings at the ESC Congress 2013 in Amsterdam organized by the European Society of Cardiology. Their new study results show among patients undergoing percutaneous coronary intervention (PCI) with stents, the risk of cardiovascular complications after stopping dual antiplatelet therapy (DAPT) is highly variable depending on the context, and some patients experience no complications at all.

Siemens’ PETNET Solutions has announced a three-year agreement with The US Oncology Network to supply its entire portfolio of Food and Drug Administration (FDA)-approved positron emission tomography (PET) radiopharmaceutical agents at each of PETNET Solutions’ current Good Manufacturing Practices (cGMP)-certified locations throughout the United States.

Biotronik announced the highly-anticipated results of the Reform study. The study demonstrates that ICD (implantable cardioverter-defibrillator) patients with Biotronik's Home Monitoring can enjoy a reduction in follow-up visits by 58 percent. This in turn leads to patients reporting enhanced quality of life.

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