Drug Coated Stents Lawsuit & News Blog

Abbott’s and Medtronic’s new stents may be easier to insert, but not safer than earlier generation products

Sun, 13 Jan 2008 09:55:03 -0500

According to a report in the Financial Times, two drug-eluting stents entering the medical device market are easier for surgeons to insert, but their safety and efficacy profiles will be comparable to their predecessors, physicians told Pharmawire. And the prior stents have shown problems, so this is not a step in the right direciton.

Stents and Angioplasty: Do these procedures protect against heart attacks?

Wed, 11 Apr 2007 16:07:37 -0500

Recent articles in the New England Journal of Medicine have editorialized on the effectiveness of stents and angioplasty vs. other methods of medical therapy heart attack prevention techniques.

From 1999 to 2004 1,149 mostly male Caucasian patients with stable coronary artery disease underwent stent surgery and/or angioplasty along with medical therapy while 1,138 mostly male Caucasian patients with stable coronary artery disease solely received medical therapy only.

In the stent plus medical therapy group there were 211 medical events including heart attack and non-specific death vs. 202 medical events heart attack and non-specific death in the medical therapy group only. Medical therapy is considered as a reduction of risk factors and lifestyle intervention.

All patients were from the Veterans Administration and were given 81 to 325 mg of aspirin per day or clopidogrel, if unable to take aspirin. All patients received medication to lower LDL (low density lipoprotein).

As with most studies, findings are not totally conclusive. Yet, percentages of participants provide variations for and against various treatments which suggest further focused studies may be needed. One thing to realize is that the patient population must be taken into consideration for any study as to their high and low risk factors.

In the COURAGE trial (clinical outcomes utilizing revascularization and aggressive drug evaluation) patients were successful in achieving goals for both lipid levels and blood pressures. Unfortunately they had less success meeting more difficult objectives such as weight loss, smoking cessation, and increased exercise - all requiring lifestyle changes.

The use of stents and angioplasty decreased chest pain and short term performance but did not prevent heart attacks and death.

If your doctor suggests stents and/or angioplasty to prevent a heart attack, please ask him to read the following study and consider your options. If you or a loved one is the recipient of a stent and have experienced serious health problems and blood clots, you may wish to consider consulting a lawyer about a personal injury or unsafe medical device lawsuit. Please contact Anapol Schwartz for your free legal consultation.

NY TIMES REPORTS: New Trial Shows Drugs Equal Benefits of Artery Stents by Barnaby J. Feder

Tue, 27 Mar 2007 05:58:11 -0500

Many heart patients routinely implanted with stents to open arteries gain no lasting benefit compared to those treated with drugs. According to the study, patients treated withs tents don't live longer. This puts the entire stent industry into question. Clearly this study will decrease the use of stents by cardiologists. If drugs work just as well, except in the initial time frame right after a heart attack, then there seems to be little reason to implant a permanent device into the patient. Adding to this is the increased risk identified in some studies of medicated staents actually causing heart attacks later. So if ther eis no long term benefit and poerhaps an added long term risk, maybe doctors willstart to seek alternatives to the stent procedures.

Keith J. Winstein, Wall Street Journal 3/15/07 (Subscription Only) - Reports on Biliary-Stents

Thu, 22 Mar 2007 18:31:54 -0500

FDA Contests Biliary-Stent Marketing: "Food and Drug Administration staffers warned makers of bile-duct stents that the agency believes a number of them may be promoting the devices for unapproved vascular uses. At a Monday meeting in Washington with 10 to 20 stent makers, FDA staffers, including the head of its medical-devices unit, instructed manufacturers to detail how they would rein in their sales staffs, according to several people familiar with the matter. The agency displayed manufacturers' Web sites that it said crossed the line into unauthorized territory. It is illegal to market devices for uses other than those for which they were approved."

Boston Scientific's Stent Sales Fall

Tue, 16 Jan 2007 10:30:00 -0500

Boston Scientific Corp. said fourth-quarter sales of its Taxus drug-coated stent fell nearly 12 percent from the previous quarter, but the medical device maker expects the slumping stent market to rebound from recent safety worries.

Boston Scientific said sales of the Taxus stent will total about $506 million in the fourth quarter down 12 percent from the third quarter's $572 million and down 17 percent from the fourth quarter of 2005, when sales were $606 million.

After completing its $27 billion acquisition of Guidant Corp. in April, Natick-based Boston Scientific has struggled to overcome downturns in its two key heart device markets.

Drug-coated stent sales have fallen off amid recent concerns that the devices may put patients at slightly higher risk for blood clots than older bare-metal stents. And sales of the implanted defibrillators Boston Scientific acquired in the Guidant deal have been hurt by recalls and safety warnings of Guidant products.

Johnson & Johnson Gets OK to Buy Stent Maker

Fri, 12 Jan 2007 10:31:40 -0500

Johnson & Johnson received clearance from U.S. antitrust regulators to complete its $1.4 billion acquisition of Conor Medsystems Inc., a maker of heart devices.

The proposed transaction is expected to close after a meeting of Conor stockholders set for Jan. 31.

Conor Medsystems, based in Menlo Park, Calif., develops drug-coated stents that use absorbable materials to reduce the risk of blood clots.

Drug-coated stents from Johnson & Johnson and Boston Scientific Corp. were linked to blood clots in recent studies, and third-quarter sales of the devices fell. Conor's stent, which delivers multiple drugs through a coating later absorbed by the body, would give Johnson & Johnson a product that hasn't shown the same risk in trials.

New Theory to Drug Coated Stent Danger

Wed, 10 Jan 2007 10:31:11 -0500

Researchers may have discovered why drug-coated stents can cause potentially fatal blood clots to form in the coronary arteries. The stents may hinder the heart's natural ability to form collateral blood vessels that can salvage heart muscle by re-routing the blood supply. In a study of 120 patients, there was a 30 to 40 per cent less collateral blood vessel function in those implanted with the drug-coated stents, compared with the bare-metal stents, six months after implantation.

The theory was submitted by Swiss researchers and published in the Journal of the American College of Cardiology.

Is the FDA in bed with the heart stent maker?

Sun, 17 Dec 2006 08:18:58 -0500

Drug coated stents implanted to help the heart are causing fatal blood clots and death. The FDA panel just ruled that these stents have more benefits than risks. What can you do? Has a loved one suffered a blood clot from an implanted stent? Do you need to talk to a stent lawyer about a no-cost-to-you lawsuit? Contact us for a free legal consultation now:

Too Many Stents Being Used in Heart Surgery

Fri, 15 Dec 2006 11:38:11 -0500

Last year, Johnson & Johnson and Boston Scientific together sold more than one million drug-coated stents. They have become a primary treatment for the number one cause of death in the United States - heart disease.

People with a drug-coated stent seemed unusually vulnerable to blood clots in later years. The new stents solved one problem, but for many may have created another. So the F.D.A. summoned its cardiology advisers to review the evidence.

After listening to testimony, they concluded that for healthier patients with simple forms of heart disease, the benefits of drug-coated stents appeared to outweigh the risks. The picture was less clear for people with diabetes, multiple blocked arteries or other complications.

One study after another has found that whether or not a stent is coated, angioplasty - the process of opening up an artery before a stent is inserted - and stenting do not actually reduce the risk of heart attack or extend life span for most patients. But no federal agency or medical group takes action when an expensive form of treatment becomes far more common than it needs to be - which is a big reason that health care spending is rising so rapidly. (The Ledger)

New Stents Raise Safety Concerns

Fri, 15 Dec 2006 11:35:54 -0500

A flurry of recent research has raised alarm about the safety of a new generation of stents that have quickly become the most commonly used devices for treating clogged arteries, creating widespread concern about how to care for millions of heart-disease patients.

The stents, tiny drug-secreting mesh tubes used to prop coronary arteries open, appear to carry a small but significantly increased risk of causing blood clots, compared with older "bare metal" versions. The newer supposedly better drug coated stents may boost the chances of suffering a heart attack or dying, according to recently released studies.

The situation illustrates the potential dangers of assuming that new technologies are better and of adopting them widely before long-term studies are done. (Washing Post)