FDA Grants Premarket Approval To AbioMed Heart Pump Reply

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 function who are undergoing high risk PCI but who are not candidates for surgical revascularization.

Click here to read the full post on Forbes.

 

A Requiem for Routine Clot Removal During Heart Attacks Reply

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 which a device extracts the clot prior to the delivery of the stent. Following earlier success in small trials, the benefits of thrombectomy became controversial when a large trial, TASTE, found no evidence of benefit for the procedure.

TOTAL (Trial of Routine Aspiration Thrombectomy with PCI versus PCI Alone in Patients with STEMI), one of the largest trials ever to test a medical device, was presented at the American College of Cardiology meeting in San Diego and published simultaneously in the New England Journal of Medicine.

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Encouraging Long Term Results For Less Invasive Heart Valves Reply

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 were not surgical candidates and then for patients who were at high risk for surgery. One important lingering concern about TAVR was whether its results would prove to be sufficiently durable. Now the final 5 year findings from the trial, published in two papers in the Lancet, provide strong reassurance regarding the durability of TAVR. (The PARTNER trial used the Sapien TAVR device from Edwards Lifesciences. Current TAVR devices are made by Edwards and Medtronic.)

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AstraZeneca Drug ‘Approaching The Point Of Diminishing Returns’ Reply

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 over a long period ;but only at the cost of more bleeding complications.

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

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.

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

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 TAVR, many observers have been eagerly awaiting information about its use in the real world.

Now a new report published in JAMA offers the best perspective yet on the introduction of TAVR in the US with an analysis of  the one year outcomes of the first group of patients who underwent the procedure.

Click here to read the full post, with comments from Sanjay Kaul and Ajay Kirtane.

Study Uncovers Confusion About When To Use An Important Heart Test Reply

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 a very rough indication of when it should and should not be performed, but that a great deal more work needs to be done before the criteria can be considered broadly reliable.

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Hospitals, Like Vampires, Want Your Blood Reply

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 this testing can be.

Researchers analyzed records from 1,894 patients who had cardiac surgery at the Cleveland Clinic and calculated the frequency and total volume of blood drawn from their subjects. They wrote that they “were astonished by the extent of bloodletting” they discovered.

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Original illustration by Max Husten

Original illustration by Max Husten

 

 

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

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 drawing boards to redesign the devices.

Click here to read the full post on Forbes.

 

Three Trials Show Benefits Of Thrombectomy In Stroke Patients Reply

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 presented today at the AHA/ASA International Stroke Conference in Nashville; two of the trials were published simultaneously in the New England Journal of Medicine.

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Novel Device Offers Hope For Heart Patients With No Alternatives Reply

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, is a coronary sinus reducer system. It is delivered through a catheter to the coronary sinus, where it is then expanded with a balloon, blocking flow through most of the vessel except for a small central orifice. Once in place the device causes an increase in coronary sinus pressure that appears to relieve angina, though the authors acknowledge that the “physiological rationale for a beneficial effect… remains unclear.”

Investigators in the Coronary Sinus Reducer for Treatment of Refractory Angina (COSIRA) trial studied 104 patients with angina class III or IV angina who were not considered suitable candidates for revascularization.

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FDA Approves New Heart Pump From Abiomed Reply

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 rate was 73% at 30 days.

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New Device to Lower Resistant High Blood Pressure Shows Early Promise 1

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 letting some of the blood drain off into the veins.

In a paper published in the Lancet, European investigators report the results of an open-label trial in in which 83 patients with persistent high blood pressure despite taking multiple antihypertensive drugs were randomized to implantation of the Coupler device or current treatment…

Click here to read the full post on Forbes, including comments from Franz Messerli, Sripal Bangalore, and Deepak Bhatt.

 

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

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.

 

MDT DCB

New Devices May Bring Improved Treatment To Stroke Patients Reply

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 devices are retrievable stents that extract blood clots from inside vessels.

MR CLEAN (The Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), published in the New England Journal of Medicine today,  was designed to address the limitations of these previous trials. 500 patients with ischemic stroke were randomized to usual care or the addition of intraarterial treatment within 6 hours of symptom onset.

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

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 else now available–  will have a major impact on the large and important anticoagulant market.

FXI-ASO, under development by Isis, is an antisense oligonucleotide that reduces the level of factor XI, a key component of the intrinsic (contact) coagulation pathway. All the currently available anticoagulants target the extrinsic (tissue factor) coagulation pathway.

Click here to read the full post on Forbes, including detailed perspectives by Sanjay Kaul and Ethan Weiss.

 

Big Study Looks At Length of Drug Treatment After Stent Implantation Reply

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 Dual Antiplatelet Therapy (DAPT) trial was coordinated by the Harvard Clinical Research Institute as part of a large-scale collaboration with the FDA, stent manufacturers, and pharmaceutical companies…. The main results of the trial were presented on Sunday at the American Heart Association meeting in Chicago and published simultaneously in the New England Journal of Medicine.

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Nonobstructive Coronary Artery Disease Linked to Elevated Risk Reply

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.

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Aortic Valve Surgery for Nonagenarians Reply

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 Surgerydoctors at the Mayo Clinic reviewed their experience with 59 patients age 90 or older who had severe aortic stenosis and underwent surgical (SAVR) or transcatheter aortic valve replacement (TAVR).

Click here to read the full post on Forbes.

 

First Drug-Coated Balloon Approved By FDA For Leg Blockages Reply

The FDA today announced that it had approved for use in the US the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the thigh and knee (superficial femoral and popliteal arteries). The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012.

Click here to read the full post on Forbes.

 

Novel Boston Scientific Device Headed For Another Rough FDA Panel Reply

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 a decade and its approval has twice been postponed by the FDA.  Briefing documents released ahead of Wednesday’s panel suggest that the third time may not be the charm for Watchman, though close FDA watchers believe the device may ultimately squeak through.

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Cardiology Group Withdraws ‘Choosing Wisely’ Recommendation Reply

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 nonculprit lesions in heart attack patients should be performed.

The original recommendation was based on non-randomized studies suggesting that treating all significantly blocked vessels in heart attack patients could be harmful. “However,” the ACC now states, “over the last two years, new science has emerged showing potential improvements for some patients in their overall outcomes as a result of complete revascularization.”

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Fractional Flow Reserve Gains Support in Stable CAD and NSTEMI Reply

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 interventional cardiology community.

Bernard De Bruyne presented 2-year results from the FAME 2 (Fractional flow reserve versus Angiography for Multivessel Evaluation 2) study (simultaneously published in the New England Journal of Medicine). FAME 2 was designed to find out whether PCI, with the help of FFR, can reduce the rate of hard endpoints in stable coronary artery disease compared to medical therapy. (FAME 2 was sponsored by St. Jude Medical, which makes  an FFR pressure wire. Another major player in the field is the Volcano Corporation.)

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Principal Investigator Of Suspended Cytori Stem Cell Trials Remains Hopeful Reply

Shares of Cytori Therapeutics took a big bit hit today after the company disclosed in a press release that it had suspended enrollment in its ATHENA and ATHENA II trials. This kind of news is never a good sign, but the   principal investigator of the trial tells me that he believes the current problems are surmountable and that the trials are still viable.

Click here to read the full post on Forbes.