Medical Equipment Devices and Stents- Part I of a II Part Series

Editor's Note- Because of the length of this article it is now being continued in Medical Equipment Devices and Stents- Part II. With that said we will continue to add items to Part I of this article that deal with the ongoing issue of approval of unsafe medical devices by the FDA.

(5/2/09)- Dr. Donna-Bea Tillman, director of the FDA's office of device evaluation, sent an e-mail message on April 10 announcing an "all-hands meeting" to discuss the strategic direction of the device center. This type of meeting has not been held for all scientists within the device evaluation office for several years.

Nine dissident scientists had previously signed letters to President Obama and others in the administration charging that agency officials had acted illegally and that patients were routinely put at risk by medical devices approved for sale despite significant and often unanimous objections from scientific reviewers. Please see our item dated 2/10/09 below.

Recently the scientists had sent numerous e-mails to Dr. Joshua Sharfstein, the agency's principal deputy commissioner, pleading for intervention.

Legislation has been introduced in Congress that would ask the Institute of Medicine to investigate concerns about the medical device division of the FDA. The Government Accountability Office released a report in January that was quite critical of this department in particular.

(2/10/09)- The FDA's medical equipment department divides the products brought before them into three groupings. Class I devices are largely exempt from review. Included in this grouping are simple devices such as tongue depressors and reading glasses. Class II devices include mercury thermometers, and this is an area of minimal safety review.

Class III devices include pacemakers, replacement heart valves and stents. Congress mandated that Class III devices must prove through extensive testing that they are safe and effective products. A recently released report from the Government Accountability Office was very critical of the FDA's medical device testing area. It determined that extensive testing was not done on many of the devices that were approved by the department

Nine of the scientists in this department sent a letter to President Obama, in which they criticized the department and leaked several agency documents and e-mails showing the improper procedures that occurred in the department. The letter included a detailed list of laws that they claim were violated by agency officials, thus allowing unsafe medical equipment products to be sold in the marketplace.

The North American Spine Society (NASS), a medical society representing over 5,000 spine surgeons has adopted a new disclosure policy that will apply to doctors who present studies at future medical conferences. The policy requires that researchers disclose not just the existence of financial ties to medical-device companies, but the dollar amounts as well.

The society said its policy "is not a voluntary guideline, but a binding covenant which applies to all relationships engaged in by all participants in all" activities of the spine society. Violations of this policy could include suspension, expulsion or public censure to a member of the society. The sanction would not restrict a violator from continuing to practice medicine, but would be a blot on the record of a member who was censured

(1/31/09)- The federal appeals court in Washington, D.C. reversed the jury decision and threw out a Delaware court's 2005 patent violation jury decision in favor Boston Scientific's Taxus stent against Johnson & Johnson's Cypher stent. Boston Scientific alleged that the Johnson drug coated stent violated a patent that Boston Scientific had been awarded in 2000.

The appellate court ruled that the patent was not innovative enough and was invalid in light of a 1996 patent on drug coated stents held by Medtronics Inc. A jury in that same lower Delaware court had ruled in favor of Johnson & Johnson in a patent suit brought by that company against Boston Scientific. The lower court jury in that case awarded Johnson $703 million, and that case is being appealed by Boston Scientific.

The Washington Appellate Court has the final say in all patent litigation cases, and they can not be appealed to the U.S. Supreme Court.

(1/18/09)- U.S. District Court Judge Richard H. Kyle, in Minneapolis has dismissed a class action suit against Medtonics Inc. citing the U.S. Supreme Court's February ruling (Riegel vs Medtronics) that federal law "pre-empts" product liability lawsuits under state law. Even though the judge stated that this might be inequitable, it would be up to Congress to remedy the matter.

At issue was the Medtronic Sprint Fidelis defibrillator that was pulled from the market by the company in October 2007. This device had been implanted in 268,000 patients world wide when it was pulled from the market because the company determined that the lead wire was failing at an unacceptable rate.

Hunter Shkolnik, a New York lawyer representing 850 patients, said he and colleagues plan to appeal the Minneapolis decision. The company argued that since the FDA approved the product, state laws could not question that approval through product-liability lawsuits.

(10/24/08)- Boston Scientific Corp said that the FDA had approved its Taxus Liberte drug-coated stent, even though the government has not lifted its moratorium on new products that was first instituted in January 2006 over quality-control practices.

Karen Riley, a spokeswoman for the FDA said, "After careful review and consideration, we can decide to approve a product while a warning letter is still open".

Boston Scientific ads promoted the Liberte as easier to implant than its Express stent product, and is just as good at preventing arteries from reclogging after implantation. A Wall Street Journal had questioned the data submitted by the company to show that the Liberte was better than the Express. The company has denied that it had overstated the results of the study.

(10/18/08)- In our article on Continuing Medical Education we discussed the settlement between the Justice Department and the manufacturers of hip and knee replacement medical equipment companies of the government suit for failure to give Medicare and Medicaid the lowest prices for their products because of rebates and discounts given to surgeons who implanted their devices.

The matter of "deferred prosecutions" and the appointment of monitors is also discussed in that article. It now comes to light however that the legal travails of Stryker Corp and the Justice Department is still making news.

The news that Stryker is seeking to set aside a subpoena that it has received in August from the Department of Health and Human Services indicates that the matter has still not been resolved.

Four other medical equipment manufacturers paid a collective $311 million fine and signed deferred prosecution agreements with the Justice Department. Stryker cooperated at first but did not sign a non-prosecute pact or pay any fine whatsoever.

The company was not released from civil liability. The matter came to light when Stryker sought to set aside a subpoena it had received late in August, with the reply to be made in the U.S. District Court for the Western District of Michigan. Stryker's company headquarters is in Michigan, whereas its orthopedics division is headquartered in N.J.

Judge Robert J. Jonker is handling the matter in the Michigan court and he laid out a briefing schedule that runs through December 15th.

Please also see our item dated 5/30/08 below in respect to the FDA's action against some of Stryker's plants.

(9/4/08)- The early results of a study that compared Boston Scientific's drug eluting stent Taxus to bypass surgery in seriously ill patients, indicated that the surgery was the better course of action. The study, named Syntax, was sponsored by Boston Scientific.

The Syntax study was the first large-scale data gathering examination that evaluated drug coated stents as opposed to bypass surgery. It included about 3,000 patients at 85 hospitals in the U.S. and Europe and is estimated at having cost over $50 million.

The results were unveiled at a cardiology conference in Munich. To qualify as a seriously ill heart patient in the study, the individual had to have either at least three clogged arteries, or a single clog in the heart's "left main" artery.

After one year, 17.8% of stent patients had died, suffered a stroke or heart attack, or had to return for another operation. Only 12.1% of bypass patients had the same problem.

Once full results from the study are known, Boston Scientific promised to publish a " weighted Syntax score", which is a statistical tool for deciding, based on a patient's individual blockage, which procedure may be best. Results will also be released concerning patients' health after three years and five years.

Taxus is the world's top selling drug-coated stent with about $1.8 billion in sales last year.

(7/20/08)- According to a survey of 60 U.S. hospitals that was done by Goodroe Data Warehouse, a unit of VHA Inc. of Irvington Texas, 73% of the stent procedures done in the month of June used a drug coated one. That was up from 62% in December, and brought it to the highest level that it has been at since the whole dispute arose about their usage in February 2007.

Coated stents commanded about 88% of the U.S. stent market as recently as two years ago.

"People initially had a wave of shock" over the safety concerns, said William O'Neil, a cardiologist at the University of Miami Medical School. "Since then, I think there's been a more sober appraisal, and the final reality's coming out."

(7/5/08)- The results of a new study on about 67,000 Medicare patients who were treated before and after the first drug coated stent from Johnson & Johnson showed that the stent treated patients were less likely to need repeat procedures and weren't more likely to die or have a heart attack. The results of the study were published in a recent edition of the Journal of the American Medical Association.

Johnson & Johnson's Cypher stent was the first one approved for sale by the FDA in 2003. The National Institute on Aging and the Robert Wood Johnson Foundation, which was founded by the family that started J&J, funded the study.

David Malenka, a cardiologist at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H. was the lead author for the study. Dr. Malenka has received research funding from Abbott Laboratories and Guidant Corp.'s endovascular business, which is now part of Abbott.

The new study included 38,917 Medicare patients who had stent procedures between October 2002 and March 2003, before any drug coated stents were approved, and then 28,086 patients who received stents between September and December 2003 when J&J's stent became available.

The study found that 23% of patients treated in the bare metal era had a repeat procedure such as antioplasty with a balloon or stent, or bypass surgery, through two years of follow-up. The rate was 19% among patients treated after J&J's stent became available.

When adjusted to account for differences among patients, those treated in the coated-stent era saw an approximate 18% reduction in repeat procedures. The unadjusted mortality risk at tow years was the same for patients in both groups, at 8.4%, while there was a slightly decreased risk of heart attacks among patients treated after coated stents were available, according to the study.

(5/18/08)- The results of clinical trial data of Abbott Laboratories drug-coated stent Xience V compared to Boston Scientific Corp.'s Taxus, drug coated stent was presented at the EuroPCR conference in Barcelona Spain recently.

The analysis by Abbott two years after its Xience V stents were implanted in patients showed that they are as safe as, and potentially more effective than the market-leading version made by Boston Scientific.

Please keep in mind that a stent does not have to prove it is better than stents that have already been approved by the FDA, only that it is as good as previously approved stents.

Xience has already been approved for usage in Europe but is still awaiting approval in this country. In 2007, drug-eluting stents had $1.83 billion in sales in the U.S. Boston Scientific's Taxus stent garnered about $1 billion in sales, while J&J's Cypher stent had about $825 million in sales. In February 2007 Medtronic's Endeavor DES was approved for sale in the U.S.

The latest findings were for a two-year period of time versus the earlier one-year data that was published in the Journal of the American Medical Association last month.

Although the question has arisen as to whether or not drug-coated stents are as safe as the non-coated stents, the matter still is open to question. Many medical professionals feel that the bare stents are less clot prone than the coated stents, but this question is still being debated in medical circles.

Xience's safety was questioned by an FDA panel at its meeting in November because of its lack of long-term data. This recent data goes a long way towards resolving that matter according to John Somberg, and FDA panel member and professor of medicine and pharmacology at the Rush Institute in Chicago.

(4/2/08)- The FDA proposed tougher clinical-trial guidelines for drug-coated stents in response to the reported blood clotting issues long after implantation. These guidelines resulted from hearings and public comments before the FDA at a two-day hearing held in December 2006.

The risk of clotting around both drug coated and plain stents has been highlighted in the media in the last few years. So far, there has been no definitive proof that drug-coated increase the risk of clotting compared to the older non-coated stents. The issue as to whether or not the risk increases with the passage of time has come to the forefront of the debate recently.

The guidelines will not affect coated stents already on the market, or cause further delays at Bostoni-Scientific, which is still under a new product probation from the FDA for its next generation heart stent in the U.S.

The proposed new guidelines will require a company to submit trial data on patients' health one and two years after the procedure before stents can be approved. The FDA's new guideline will require companies to continue monitoring the devices for five years after implantation for five years for blood clots, heart attacks or other complications.

The FDA guidelines aren't legally binding, but most companies follow them to ensure approval of the devices.

(2/2/08)- Medtronic Inc. announced that it had received approval from the FDA to market its drug eluting stent Endeavor. For more on this please see our item dated 10/15/07 below, wherein the advisory panel had voted to recommend the stent to the FDA.

Approval had been expected within the December/January time frame, so with the formal approval the company began an immediate launch of 100,000 of the stents within the next 30 days to the market. Endeavor is now the third drug eluting stent on the market that includes Boston Scientific's Taxus stent and Johnson & Johnson's Cypher stent.

The approval for the sale of Endeavor was conditioned on the requirement that Medtronic conduct a five-year study, with at least 5,000 patients that examines the blood clot risk of the device.

Medical equipment analysts now estimate that is will be about 3 1/2 months before Abbott Laboratories Inc.'s Xience V drug eluting stent receives approval to be marketed. For more on this topic please see our item dated 12/8/07 below. 

(1/20/08)- U.S. regulators have warned artificial hip, shoulder and knee maker Stryker Corp. about manufacturing problems linked to manufacturing hip parts at times serious enough to require additional surgery.

The letter posted on the FDA Web site said infractions at the company's Mahwah, N.J. plant, including those related to its Trident hip-replacement systems, was dated November 28, 2007.

The company's hip, knee and shoulder replacements are a major revenue generator with worldwide sales of $2.6 billion for the first nine months of 2007, according to the company's most recent financial report.

The FDA letter cited complaints from January 2005 to April 2007 " for squeaking noises of hip implants with ceramic-bearing components."

Such problems resulted in additional surgeries for implant failures such as fractures and pain. The FDA sent the company an additional letter warning about a plant in Ireland last March, citing the company's failure to remedy quality problems at that plant.

More than half of the company's reconstructive products are made at those two plants, according to BMO Capital Markets.

(12/18/07)- The FDA's device chief Daniel Schultz said that the agency will issue guidelines in the next few weeks for drug-coated heart stents. The agency held a two-day meeting last December over the concern that the drug-coated stents may have a greater risk for blood clots than do the uncoated stents.

The new guidelines will probably cover items such as the numbers of patients whom the new stents must be tested and for how long. They may also require a testing period data study after the device has been in use for a longer period of time, with a public announcement of these results. The new guidelines are expected to discuss the length of time that it will be recommended for the recipients to take the anti-clotting drug Plavix after getting the stent.

The new guidelines won't affect those stents that are already on the market, or models from Medtronic Inc.(Endeavor) and Abbott Laboratories (Xience) that appear to be on the verge of approval.

(12/8/07)- An FDA panel voted 9 to 1 in favor or recommending approval of Abbott Laboratories drug-coated stent named XienceV. Abbott acquired the stent when it bought part of Guidant Corp. last year for $4.1 billion. Boston Scientific Corp. purchased the main part of Guidant after it had outbid Johnson & Johnson for the company.

The panel voted for the approval of the stent in dealing with cardiac blockages even though it had concern over the lack of long-term data for the product. The main clinical study submitted to the FDA in support of Xience involved 1,002 patients who were initially followed for one year. The panel recommended that the FDA require a post-market study, which Abbott has already agreed to conduct.

Abbott said that it expects to complete two-year data next year. The study compared 422 patients who have had Xience for two years, compared to 181 patients who had been supplied with Boston Scientific's drug-coated stent Taxus.

Please keep in mind that under FDA rules, a company does not have to prove that its medical equipmant is better than another company's product, only that it is "as good as" the other company's product.

(11/24/07)-The results of a recent study that was done on the health after two years of more than 17,000 patients who received drug coated stents in Massachusetts from April 2003 to September 2005 were released at the recent American Heart Association meeting. It showed that there was a clear advantage for drug-coated stents over the plain stents.

9.4% of the drug-coated patients had died, compared with 11.9% of those that got bare-metal stents.

The newer stents coming to market shortly have thinner struts and different coatings, which some studies suggest, are less likely to lead to late stent thrombosis. In addition to the new Medtronic stent mentioned in our item dated 10/15/07 Abbott Labs" Xience V, which Boston Scientific will also market under the Promus name may arrive on the market in the summer of 2008

(10/15/07)- A FDA advisory panel unanimously recommended that Medtronic Inc.'s drug-coated Endeavor stent be approved for sale, along with a requirement for follow-up safety studies. If, as expected, the FDA goes along with the recommendation Medtronic expects to be selling the stent by year-end.

The two other companies that sell FDA approved drug-coated stents are Boston Scientific's Taxus stent and Johnson & Johnson's Cypher stent. Abbott Laboratories is seeking approval to co-market sales of a drug-coated stent named Xience by early next year.

The approval for the sale of Endeavor was conditioned on the requirement that Medtronic conduct a five-year study, with at least 5,000 patients that examines the blood clot risk of the device.

Endeavor was implanted in more than 2,000 patients in three main clinical studies. One compared Endeavor to patients with Medtronic's non-drug-coated stent known as Driver. The other studies compared Endeavor to Cypher and to Taxus.

Overall,the FDA panel said the studies showed that Endeavor was as safe as the other devices when looking at death rates and serious problems such as heart attacks and blood clots, and it was more effective than the Driver stent at keeping previously clogged arteries open.

Bram Zuckerman, director of the FDA's cardiovascular device division, said the device makers need only to prove a device is reasonably safe and effective, and not necessarily better than a similar device on the market, to gain FDA approval.

The trials suggested however that Endeavor, which releases its drug unusually rapidly-95 percent of it within 10 days- is less effective at keeping blood vessels open than is Taxus or Cypher..

(9/16/07)- The analysis of a recent large study comparing drug-coated heart stents against bare metal stents concluded that the former do not run a higher risk of death. The results of the analysis was published in a recent edition of The Lancelot, the London based medical journal. The study concluded that the drug- coated stents did not raise the risk of death over the rate of death for the bare-metal stents.

The study combined and reanalyzed the latest data available from 38 previously reported clinical trials. The 29 multinational doctors who collaborated on the article pooled results from the 38 trials into a metaanalysis. The analysis also compared Boston Scientific's drug coated stent Taxus to Johnson & Johnson's drug coated stent Cypher. Data for this comparison came from reevaluating the data from more than 18,000 patients in clinical trials where one of the two drug-coated stents was compared to a bare-metal one.

The data also suggested that patients who received the Taxus stent were a bit more likely to suffer heart attacks than those who received the Cypher stent. Those who received the Taxus stent ran a slightly higher risk of potentially deadly clots forming within 30 days after the implantation compared with bare-metal stents. This risk was not evident in those who received the Cypher stent.

Sales of drug-coated stents will total about $5.5 billion worldwide this year according to the Millennium Research Group, a market research company in Toronto. Medtronic Inc and Abbott Laboratories hope to get final approval for their versions of drug coated stents from the FDA this year.

(6/15/07)- The recent controversy about the effectiveness of drug eluting stents versus the older plain stents has now seen a further shift in that some recent studies have shown that doctors may be improperly placing the stents over the affected area, or that they are not being deployed firmly enough into the area wall, that in turn may be causing the clots.

Because of the controversy, doctors in the U.S. have curtailed their use to only about 66% of the cases, down from almost 90% before the matter arose.

The Cardiovascular Research Foundation, a staunch proponent of stent technology, is launching an 11,000 patient study designed to examine whether less-than-optimal deployment of a stent is linked to the type of clots at the center of the debate-those that occur more than a year after implantation of a stent.

The clotting problem is a rare one since it occurs in only about 0.5% of the roughly one million stent procedures done in the U.S. each year. Surgeons have been using a new medical viewing technology called intravascular ultrasound, or IVUS, to guide themselves or even to verify the proper placement of the stents.

A recent study of 1,557 patients found that about 2/3rds of the drug-coated stents were either under-inflated or failed to cover the treated area of the vessel. Johnson & Johnson, one of the major manufacturers of stents, sponsored this study.

The IVUS is however a costly piece of equipment, since it adds about $600-$700 cost to the procedure.

(5/31/07)- Medtronic Inc. said that it has enrolled the first patient in its large randomized trial designed to study the safety of drug-coated stent heart devices. The stent in question is named Endeavor, and the competitors in this field are J&J's Cypher and Boston Scientific's Taxus.

Medtronics is selling Endeavor overseas, and hopes to bring it to the U.S. this year.

The Medtronic study, called Protect, hopes to enroll 8,800 patients, and will compare its stent Endeavor with J&J's Cypher stent. The primary goal of the study is to measure stent thrombosis, or stent-related clots, at three years.

The study will enroll patients at over 200 medical centers worldwide. To see more about the study please go to

(2/6/07)- Recent research has questioned the safety and advantage of drug-eluting stents.

An article in Family Practice Jan 1, 2007 states " least 60% of DES use is off label for conditions that include in-stent restenosis, lesions, coronary artery bypass grafts, overlapping and multiple stents per vessel". There appears to be a small but significant increase in mortality and myocardial infarctions 18 months to 3 years after implantation.

This information came out of a two day conference of the FDA’s Circulatory System Devices Panel that included representatives from medical associations, FDA officials, medical researchers and drug-eluting manufacturers.

The benefits of these stents outweigh the risks when used for approved indications. Dr. William Maisel (Beth Israel Deaconess Medical Center, Boston) reports that stents when used on label show no association with an increase in deaths or heart attack, though there may be an excess of late stent thrombosis.

The alternatives to the drug-eluting stents are bare metal stents, coronary artery bypass surgery, and medical therapy.

There are two drug-eluting stents on the market: the Cypher sirolimus-eluting stent manufactured by Cordis Corporation, and the Taxus Express paclitaxel-eluting coronary stent system from Johnson & Johnson.

According to Family News (ibid) "The Cypher stent is approved for patients with symptomatic ischemic disease caused by ‘discrete de novo lesion’ that are 30 mm or less in length in native coronary arteries with a reference vessel diameter of at least 2.5 mm to no more than 3.5 mm."

"The Taxus stent is approved for improving luminal diameter of de novo lesions no more than 28 mm in length, in native coronary arteries of at least 2.5 to no more than 3.75 in diameter."

Our hope is that this basic information will prove helpful to those readers who are considering use of drug-eluting stent.



Allan Rubin and Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated May 2, 2009

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