News 2018-06-11T13:42:27+00:00

CardiAMP cell therapy receives fda approval for pivotal trial in chronic myocardial ischemia

SAN CARLOS, Calif. – BioCardia®, Inc., a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption for the CardiAMP Chronic Myocardial Ischemia (CMI) Trial to treat patients with refractory angina (RA).The CardiAMP Chronic Myocardial Ischemia Trial will be a prospective, multi-center, randomized, sham-controlled, patient- and evaluator-blinded pivotal trial to validate the safety and efficacy of CardiAMP investigational cell therapy in the treatment of patients having CMI with RA. The trial has been approved to enroll up to 343 subjects at up to 40 U.S. centers. This trial has the potential to support functional benefit claims sufficient for product registration without a second confirmatory trial. This second clinical indication of CMI with RA for the CardiAMP investigational cell therapy follows the company’s FDA-approved pivotal clinical trial of CardiAMP cell therapy in ischemic heart failure, which is currently

Terumo receives CE Mark for Ultimaster TANSEI drug-eluting stent

Granting of ‘Conformité Européenne’ a major milestone as Terumo gears up for global launches of next generation drug-eluting stent (DES) Leuven, Belgium – building on the heritage of the successful Ultimaster™ stent, the Ultimaster™ TANSEI™ features optimized technology that will benefit clinicians and their patients worldwide. Granting of the CE Mark indicates that the product satisfies the requirements of relevant EU Directives and can be marketed throughout Europe. Terumo will launch Ultimaster TANSEI in Europe in May 2018, and expand in other countries (Middle East, Latin America, and Asia) sequentially. The original Ultimaster DES has extensive real-world clinical data, having been studied in a population of over 40,000 patients. It has proven long-term safety¹ and efficacy, as demonstrated in the global clinical trial program that encompassed a wide range of different patient’s conditions, complex anatomy, and challenging procedures. “Ultimaster is a trusted brand being used by cardiologists daily in procedures

Radial Access PCI Reduces Risk of Mortality and Bleeding in VALIDATE-SWEDEHEART

The presentation spurred a debate between proponents and skeptics of the transradial approach, with some stating there is need for more US study. By Michael O'Riordan March 06, 2018 WASHINGTON, DC—Patients with acute coronary syndromes undergoing invasive management fare significantly better when treated via the radial artery when compared with femoral-access PCI, according to the results of a prespecified analysis of the VALIDATE-SWEDEHEART trial. Overall, the primary composite endpoint of death from any cause, myocardial infarction, or major bleeding at 180 days was reduced by 34% in the radial-access PCI arm compared with patients treated with femoral access (P < 0.001). There was no reduction in the risk of myocardial infarction, but the risk of death from any cause was reduced by 58% with radial access and the risk of major bleeding reduced by 43%, both statistically significant. The bleeding benefit was driven by a statistically significant 77% reduction in the risk

Movement Toward Simpler, Wearable Cardiac Monitoring

The show floors at the American College of Cardiology (ACC) 2018 meeting in March and at the Heart Rhythm Society (HRS) included numerous vendors offering small, easy-to-use, inexpensive, leadless wearable cardiac monitors. These are being offered as replacements for bulky, expensive Holter monitors or event monitors that patients wear on their belt and require wire leads to be attached to several points on their bodies. These new wearable monitors can record long periods of cardiac activity, and usually have a button for patients to use when they want to flag an event. They can be worn in the shower and while sleeping, and offer many practical advantages over the older standard event monitoring technologies. I have seen these devices gaining ground over the past few years at both ACC and HRS meetings and predict they will become the monitoring technology of choice in the future. Unlike traditional Holter and cardiac event recorders, this new generation

Plaque Dislodgement Less Frequent With Transradial vs Transfemoral PCI

Despite “striking” differences in the amount of plaque encountered, any downstream events appear to be clinically silent, at least in the short term. By Michael O'Riordan May 07, 2018 Given the anatomic distribution of atherosclerosis in the aorta, plaque dislodgement and embolization are more likely to occur with the transfemoral approach for left-sided heart catheterizations rather than with the transradial approach, according to a new viewpoint published last week in JAMA Cardiology. And while the consequences of such dislodgement are most likely “clinically silent” rather than “clinically apparent” embolization, a difference in mortality might be more obvious if patients were followed longer, argue two experts. “Despite the striking differences in the quantity of plaque encountered by a catheter during its course to the left side of the heart when inserted into the femoral artery versus the radial artery, differences in the frequencies of clinical evidence of stroke, myocardial infarction, renal injury, and

Alirocumab Reduces Cardiovascular Events after Acute Coronary Syndrome

March 13, 2018 –  Among patients with persistently high cholesterol despite high-intensity statin therapy, the proprotein convertase subtilisin-kexin 9 (PCSK9) inhibitor alirocumab reduced rates of major adverse cardiovascular events (MACE) by 15 percent compared with placebo, in a study presented at the American College of Cardiology’s 67th Annual Scientific Session. The drug’s effect was even greater for patients at highest risk—those who started the study with LDL, or “bad” cholesterol, of 100 mg/dL or higher—who saw a 24 percent reduction in cardiovascular events, including heart attack and stroke, compared with placebo. The trial, called ODYSSEY Outcomes, was conducted in patients who had recently had an acute coronary syndrome (ACS), an umbrella term that includes heart attack and unstable angina. Such patients face a substantial risk of further cardiovascular problems and related death, particularly if their cholesterol level is not adequately controlled. Alirocumab is a fully human monoclonal antibody that works by blocking PCSK9. This