Study Shows Why Sham Controls Are Necessary For Device Trials

— If we can melt the ice-caps then surely we can understand our own fallibility, says one UK cardiologist. The strongest known force in the universe is the ability of the human mind to deceive itself. If we know something to be true then we find the evidence to prove it. There is no better…

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Encouraging Results Found In Long Term TAVR Registry

Since it’s first FDA approval in late 2011 the use of transcatheter aortic valve replacement therapy (TAVR) has grown dramatically– but not dangerously or explosively– in the US. Now accumulating data from a central national registry provides the best picture yet of the evolution and current status of TAVR. The TVT Registry, which is run by the Society of Thoracic Surgeons (STS)…

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CMS Proposal Would Plug Up Watchman Reimbursement

Medicare is proposing to put severe constraints on reimbursement for percutaneous left atrial appendage closure using the Boston Scientific Watchman device to prevent stroke in patients with nonvalvular atrial fibrillation. On Tuesday afternoon the Centers for Medicare & Medicaid Services (CMS) issued the draft of a restrictive national coverage determination (NCD) for Watchman that would almost certainly apply the…

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Waiting For ISCHEMIA: Why Won’t Cardiologists Enroll Patients?

One of the most important unanswered questions in medicine today– the best treatment for stable ischemic heart disease– may never get a satisfactory answer because cardiologists are unwilling to enter their patients in a clinical trial. One major reason why the question is urgent: about a third of the 1 million PCI procedures performed each year in the…

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Clot Extraction For Stroke: Beware The Hype

Clot extraction (thrombectomy) for stroke has been on a roll lately. After the failure of a series of trials a few years ago investigators and industry went back to the drawing board. The result of their efforts– a new and improved thrombectomy– has brought about a dramatic reversal of fortune for the technology. In the past year five newer trials…

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Primary PCI Guideline Update: Multivessel Interventions In, Thrombectomy Out

The guidelines for primary PCI for ST-elevation MI (STEMI) have been updated to reflect major findings from recent trials: PCI of a noninfarct artery is now acceptable for some STEMI patients with multivessel disease. In previous guidelines PCI of noninfarct arteries had been considered unsafe. Routine thrombectomy prior to primary PCI for stent implantation is now…

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New Concerns Raised About Bioprosthetic Aortic Valves

New, potentially important concerns have been raised about bioprosthetic aortic valves, both those  implanted during surgery and those during a catheter-based procedure (TAVR). Investigators from three separate groups reported on their troubling findings in a paper published in the New England Journal of Medicine. The article was accompanied by both an editorial and a perspective from the FDA….

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No Benefit For A Commonly Used Cardiac Device

Once again, after decades of common use, a frequently implanted device has been found to confer no benefit whatsoever over a much less invasive therapy. Cardiologists and radiologists often implant the device, called a retrievable inferior vena cava filter, inside people who are at high risk for developing potentially lethal blood clots. The filter is designed to prevent…

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Medicines Company Drug Finally Gets Nod From FDA Advisory Panel

On Wednesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2-1 to recommend approval of cangrelor during PCI to reduce the risk of periprocedural thrombotic events such as MI, stent thrombosis, and ischemia driven revascularization. … Click here to read the full post on Forbes.  …

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FDA Grants Premarket Approval To AbioMed Heart Pump

The FDA said today that it had approved Abiomed’s Impella 2.5 System. According to the company it is is the first hemodynamic support device to gain FDA premarket approval for use during high risk PCI procedures. The miniature blood pump is designed for temporary use in patients with severe symptomatic coronary artery disease and diminished (but stable) heart…

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A Requiem for Routine Clot Removal During Heart Attacks

Using a stent to open a blocked coronary artery is the treatment of choice in the early period of a heart attack (myocardial infarction). A limitation is the risk of dislodging part of the clot, leading to new downstream blockages of smaller vessels. One strategy that has been under development for a long time is thrombectomy, in…

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Encouraging Long Term Results For Less Invasive Heart Valves

The publications five years ago of the two part PARTNER trial brought a major change in the treatment options available to some people with aortic valve disease, which is often an extremely serious condition with a poor prognosis. The trial demonstrated that transcatheter aortic valve replacement (TAVR) was a reasonable treatment option, first for patients who…

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AstraZeneca Drug ‘Approaching The Point Of Diminishing Returns’

After a heart attack (myocardial infarction or MI) patients remain at high risk for recurrent events. The precise role of blood thinning with dual antiplatelet therapy to lower this risk has been the subject of considerable disagreement.  Now a new study offers fresh evidence that one important strategy, prolonged dual antiplatelet therapy, can lower risk…

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What A Long Strange Trip It’s Been: FDA Approves Watchman Device From Boston Scientific

Finally reaching its destination after an extremely long and strange trip, Boston Scientific gained approval from the FDA today to market its Watchman Left Atrial Appendage Closure Device in the US. The device has been in development for well over a decade and had been turned down by the FDA on several occasions. … Click here to…

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High Risks And Rewards Found With Heart Valve Device From Edwards And Medtronic

Transcatheter aortic valve replacement (TAVR) is one of the most important advances in cardiovascular medicine in recent years. TAVR devices, introduced recently in the US by Edwards Lifesciences and Medtronic, are associated with very high risks, but offer a less invasive alternative to traditional aortic valve replacement surgery. Because of early concerns about potential overuse and misuse of…

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Study Uncovers Confusion About When To Use An Important Heart Test

Appropriate use criteria (AUC) are designed to help make sure that medical procedures and interventions are performed in people most likely to benefit and, in turn, are not performed in people unlikely to gain benefit. Now a new study published in Annals of Internal Medicine suggests that the AUC for one very widely performed procedure, diagnostic cardiac catheterization, can provide…

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Hospitals, Like Vampires, Want Your Blood

Anyone who has been in the hospital, either as a patient or a healthcare provider, is keenly aware that hospitals perform a lot of tests. It has even been suggested that some of those tests may not be necessary. Now a new study published in the Annals of Thoracic Surgery sheds light on just how excessive some of…

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Medtronic And Boston Scientific Plan To Resume Blood Pressure Trials This Year

Medtronic and Boston Scientific have announced plans to start phase 2 clinical trials this year for their updated renal denervation catheters. The once promising new technology is intended to treat hypertension unresponsive to drug therapy. The failure last year of Medtronic’s Symplicity HTN-3, the first large pivotal trial to rigorously test renal denervation, sent manufacturers back to their…

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Three Trials Show Benefits Of Thrombectomy In Stroke Patients

Three new studies offer important additional evidence that early treatment with current thrombectomy devices that extract clots from blood vessels in the brain can lead to improved outcomes in carefully selected stroke patients. The trials were stopped early based on efficacy following positive findings last year from another trial, MR CLEAN. The three new trials were…

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Novel Device Offers Hope For Heart Patients With No Alternatives

An entirely predictable consequence of medical progress is the growing number of heart patients with persistent and symptomatic angina who have run out of treatment options. A small study published in the New England Journal of Medicine raises the possibility that a new and novel device one day may provide them some relief. The experimental device, called the Neovasc Reducer,…

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FDA Approves New Heart Pump From Abiomed

Abiomed has announced that it received FDA approval for its Impella RP System, the first percutaneous single access heart pump that provides support to the right side of the heart. The approval, under a Humanitarian Device Exemption (HDE), is based on results of the single arm Recover Right study, in which 30 patients were enrolled. The overall survival…

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New Device to Lower Resistant High Blood Pressure Shows Early Promise

A novel implantable device appears to show early promise in the treatment of resistant hypertension. The “Coupler” device from privatelyheld ROX Medical is about the size of a paper clip and is delivered via a catheter to the upper thigh, where it creates a connection between the vein and the artery, which lowers blood pressure in the arteries by…

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FDA Approves New Medtronic Drug-Coated Balloon To Open Blocked Leg Arteries

Medtronic said today that it had received approval from the FDA to market its In.Pact Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the upper leg. The device is the second DCB to gain FDA approval. Last October the FDA approved CR Bard’s Lutonix DCB for a similar indication. … Click here to read the full post on Forbes.  …

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New Devices May Bring Improved Treatment To Stroke Patients

A large new trial provides the first substantial evidence that new devices can improve the outcome of patients who have acute ischemic stroke. Earlier, less sophisticated versions of the devices had produced disappointing results in clinical trials. The previous trials may also have been hindered by long treatment delays and difficulties in recruiting suitable patients. The new…

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New Drug From Isis Breaks Important Ground But Unlikely To Dent The Market

The first important results with a new drug under development by Isis Pharmaceuticals may well have an enormous long term impact on our understanding of how blood flows through the body and how that same blood forms clots in response to damage and disease. But it appears unlikely that the new drug– an anticoagulant unlike anything…

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