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. …
FDA Grants Premarket Approval To AbioMed Heart Pump
March 24, 2015 by Leave a Comment
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…
A Requiem for Routine Clot Removal During Heart Attacks
March 16, 2015 by Leave a Comment
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…
Encouraging Long Term Results For Less Invasive Heart Valves
March 15, 2015 by Leave a Comment
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…
AstraZeneca Drug ‘Approaching The Point Of Diminishing Returns’
March 14, 2015 by Leave a Comment
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…
What A Long Strange Trip It’s Been: FDA Approves Watchman Device From Boston Scientific
March 13, 2015 by Leave a Comment
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…
High Risks And Rewards Found With Heart Valve Device From Edwards And Medtronic
March 10, 2015 by Leave a Comment
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…
Study Uncovers Confusion About When To Use An Important Heart Test
March 9, 2015 by Leave a Comment
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…
Hospitals, Like Vampires, Want Your Blood
March 2, 2015 by Leave a Comment
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…
Medtronic And Boston Scientific Plan To Resume Blood Pressure Trials This Year
February 19, 2015 by Leave a Comment
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…
Three Trials Show Benefits Of Thrombectomy In Stroke Patients
February 11, 2015 by Leave a Comment
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…
Novel Device Offers Hope For Heart Patients With No Alternatives
February 5, 2015 by Leave a Comment
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,…
FDA Approves New Heart Pump From Abiomed
January 28, 2015 by Leave a Comment
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…
New Device to Lower Resistant High Blood Pressure Shows Early Promise
January 22, 2015 by 1 Comment
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…
FDA Approves New Medtronic Drug-Coated Balloon To Open Blocked Leg Arteries
January 5, 2015 by Leave a Comment
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. …
New Devices May Bring Improved Treatment To Stroke Patients
December 17, 2014 by Leave a Comment
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…
New Drug From Isis Breaks Important Ground But Unlikely To Dent The Market
December 7, 2014 by Leave a Comment
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…
FDA Approves New Noninvasive FFR Technology
November 26, 2014 by Leave a Comment
The FDA said today that it had granted approval to a novel technology that noninvasively measures fractional flow reserve (FFR) using data obtained from a CT scan of the heart…. … Click here to read the full post on Forbes. …
Big Study Looks At Length of Drug Treatment After Stent Implantation
November 16, 2014 by Leave a Comment
The advent of drug-eluting stents dramatically reduced the restenosis (reclogging) rate associated with bare-metal stents but prompted new concerns about the rare but potentially lethal complication of stent thrombosis (ST). Cardiologists have relied upon dual antiplatelet therapy to prevent ST but there has been considerable uncertainty and controversy about the ideal duration of therapy. The…
Nonobstructive Coronary Artery Disease Linked to Elevated Risk
November 5, 2014 by Leave a Comment
A large number of people who undergo elective coronary angiography are found to have nonobstructive coronary artery disease, and these patients have significantly increased risk for myocardial infarction and death, according to a retrospective study published in JAMA. … Click here to read the full post on Forbes. …
Aortic Valve Surgery for Nonagenarians
October 30, 2014 by Leave a Comment
As people continue to live longer physicians are increasingly confronted with very elderly patients who have serious conditions that might benefit from surgery but who are at high risk for surgical complications. In a paper published in the Annals of Thoracic Surgery, doctors at the Mayo Clinic reviewed their experience with 59 patients age 90 or older who…
Novel Boston Scientific Device Headed For Another Rough FDA Panel
October 7, 2014 by Leave a Comment
On Wednesday Boston Scientific’s Watchman device will once again appear before the FDA’s Circulatory System Devices advisory panel. The Watchman is a novel catheter-delivered left atrial appendage closure device which is intended to be used in place of chronic warfarin therapy to lower the risk of stroke in people with atrial fibrillation. It has been under development for more than…
Cardiology Group Withdraws ‘Choosing Wisely’ Recommendation
September 22, 2014 by Leave a Comment
In the end it wasn’t wisdom for the ages. The American College of Cardiology said today that it was withdrawing one of its five recommendations in the “Choosing Wisely” campaign. In 2012 the ACC recommended that heart attack patients should have only their culprit artery unblocked. It said that patients and caregivers should question whether complete revascularization of all…
Fractional Flow Reserve Gains Support in Stable CAD and NSTEMI
September 2, 2014 by Leave a Comment
In recent years interventional cardiologists have started to use a new catheter technique, called fractional flow reserve (FFR), in an attempt to assess which blocked vessels might benefit from a stent. Two studies presented at the European Society of Cardiology meeting in Barcelona offered new support for FFR, which has been slowly but surely gaining traction in the…
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