Vascular Device Forum

Drug Eluting Stent Taxus fails to show superiority

From the European desk of Medical Device Daily, the results of the Syntax Study presented at the congress of the European Society of Cardiology has left cardiologists scratching their heads and stent manufacturers searching for a believable spin. In the end, the Syntax Study failed to show non-inferiority for DES (Drug Eluting Stents) vs open Coronary revascularization.

The study involved the Taxus stent from Boston Scientific with a primary endpoint of death, stroke or myocardial infarction

Source

New Innovation in Coronary Bare Metal Stent technology

As the controversy regarding drug eluting stent technology evolves, innovations in bare-stent technology are timely

Today, OrbusNeich announced plans to hire 150-200 new employees in the US over the next two years. OrbusNeich is a maker of innovative bare metal stent technology. The Hong Kong based company, which has its US based facility in Fort Lauderdale, needs to develop clinical and research teams to begin its US based research trials. OrbusNeich's stent, known as the blazer, is already available in Europe, the middle east and South America.

If all goes well, the trial which would follow patients for about nine months would produce results by 2010. The trial will be performed at a cost of $5-10 million.

Stephen Dunn, director of research at Boca Raton-based Dawson James Securities, said the health concerns raised about drug-eluting stents in clinical trials has opened the door for bare metal stents to grab a larger piece of the market. Bare metal stents also cost less, making them preferred by the insurance industry and government health programs, Dunn added.

OrbusNeich is also working on a hybrid stent. It would have the antibodies on the inside and a drug coating outside. That one is in development in Fort Lauderdale.

In order to fund a U.S. clinical trial for the Genous or the hybrid stent, OrbusNeich is considering a public offering in the U.S., Camp said. Other options include a private equity investment or a partnership with a larger corporation.

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Top Ten Cardiovascular and Peripheral Vascular Early stage companies

Vascular Device Forum (VDF) cites an article in Medical Device Today which describes the top ten early stage Cardiovascular and Vascular companies. This list was created from presentations at the "Investment In Innovation (In3) Medical Device Summit" on June 17-19, 2008. (Part 1 of 3)

1) Arterial Remodeling Technologies tops the list. Arterial Remodeling Technologies (“ART”) is developing bioresorbable peripheral and coronary polymer stents that promote the natural remodeling of an injured artery after angioplasty. Many industry experts are calling ART the next best thing.

2) CardiAQ Valve Technologies

3) ES Vascular technologies develops vascular staplers for open, endovascular AAA and femoral popliteal reconstructions.

7) Protomed creates sutureless techniques to facilitate rapid and safe completion of vascular anastomosis

Wall Street Journal challenges Boston Scientific's data on Taxus

Reuters reports that The Wall Street Journal is challenging the validity of data that Boston Scientific has submitted to the FDA for approval of it Taxus Liberte coronary stent system. The study was completed in 2006.

The Wall Street Journal suggests that the analysis of the data is statistically flawed due to the use of an equation called the Wald interval. WSJ states that using various off the shelf statistical analysis software systems to process the data would yield unfavorable results. The equation, used by other companies in similar studies like Medtronic and Abbott Vascular, would not have resulted in negative outcomes for these respective companies.

Source

Questionable benefit of coronary stent-the Debate continues

On the heels of diminishing revenue for the makers of coronary stent, increasing competition because of innovative technology from the likes of Abbott Vascular, market leaders like Boston Scientific and Johnson and Johnson are taking a beating.

Image from Boston Scientific

Bloomberg.com reports on a New England Journal of Medicine study which states stating-Using heart stents to prop open diseased arteries has little advantage over medicines, exercise and a better diet, according to researchers who said the devices should be a last resort for most patients.

Stents provided patients an ``incremental'' benefit in reduced pain and fatigue in a study published online yesterday by the New England Journal of Medicine. By three years, the devices lost any advantage over a regimen of anti-cholesterol drugs, increased exercise and a diet plan, the study found. An accompanying editorial said one-third of the 1 million stents implanted in the U.S. each year may be unnecessary.

Strong words I must say and  the study could prove detrimental to the industry if this gains a philosophical foothold.

The study is reported on Reuters.com and AHN.com

Equine pericardium lined stents...The Answer??

The Over and Under Pericardium Covered Stent (PCS) is a unique coronary stent from ITGI Medical. It is designed to create a barrier between the blood vessel wall and lumen and theoretically decrease the risk of re stenosis. This device is indicated for the treatment of de novo, recurrent vein graft lesions or perforations. Are equine pericardium lined stents the answer to restenosis

In other news it is reported by the Dow Jones Newswire that the Cleveland Clinic Foundation has announced plans to encourage interventional cardiologists to choose from an approved list of drug eluting stents which does not include the Boston Scientific TAXUS. Boston Scientific previously signed a deal in 2006 to serve as the preferred vendor.

Johnson and Johnson, Medtronic and Abbott will be on the preferred list. Interestingly, a recent study showed a performance advantage for the Abbott Xience vs the Taxus. Boston Scientific has a distribution agreement with Abbott to distribute an identical stent called the Promus.

Avantage: Abott Medical

Image Abbott

Medtronic Stent Thromboses trial-PROTECT

Today Medtronic announced the initiation of the PROTECT (PROTECT stands for Patient Related OuTcomes with Endeavor versus Cypher stenting Trial) trial. The trial is focused on the evaluation of the Cypher and Endeavor drug eluting stents with regards to stent thromboses.

Initiated in May 2007 with the first implants in Europe, PROTECT will enroll a total of 8,800 patients, equally randomized to the Endeavor zotarolimus-eluting coronary stent from Medtronic or Johnson & Johnson’s Cypher sirolimus-eluting coronary stent, at more than 200 medical centers globally. Enrollment through July stands at nearly 5,500 patients, more than 60 percent of the total.

PROTECT sites in the United States will serve to provide the U.S. Food and Drug Administration (FDA) with U.S.-specific data on the post-market experience with the Endeavor stent, which received FDA approval Feb. 1. The U.S. sites will enroll a minimum of 1,000 patients who receive Endeavor stents through PROTECT or, if necessary, through a nonrandomized continued-access arm

PROTECT is one such trial. With 8,800 patients, it is sufficiently powered to detect a clinically significant difference in rates of stent thrombosis between the Endeavor and Cypher stents. PROTECT’s primary endpoint is overall stent thrombosis at three years; secondary endpoints include death and non-fatal myocardial infarction (MI), as well as customary clinical efficacy endpoints, such as target lesion revascularization and target vessel revascularization. Enrollment is expected to be complete by December 2008, with three-year data on all study patients available in 2012.

Cordis J and J shakeup with more executive departures

Cordis J & J announced the departure of worldwide president Tom Pope, the seventh in a string of executives to leave during an uncertain period for coronary stent technology. As reported by Forbes.com, this occurs under the circumstances of Abbott Medical's strong showing with the Xience stent which outperformed the Taxus stent from Boston Scientfic. It is predicted that Abbott will control 47% of the market by 2011 by Wachovia analyst Larry Biegelson.

Loss is Win for Boston Scientific as Abbot's Xience V bests the Taxus stent

As previously reported, Abbot's Xience V stent outperformed Boston Scientific's Taxus coronary stent in the Spirit III trial. This is excellent news for Abbott. However, as reported previously, Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS™ Everolimus-Eluting Coronary Stent System. PROMUS is designed, studied and manufactured by Abbott and supplied as part of a distribution agreement between the two companies.

A study from JAMA, "SPIRIT III is the first large-scale clinical trial to show that patients
have a lower risk of experiencing a heart attack, cardiac death or
re-treatment when treated with a new stent, XIENCE V, compared to the most
widely used drug eluting stent TAXUS," said Gregg W. Stone, M.D., of the
Columbia University Medical Center; chairman, Cardiovascular Research
Foundation, New York; and principal investigator of the SPIRIT III clinical
trial.

There seems to be plenty of upside for Boston Scientific as a consquequence of this study which demonstrates some performance benefit

Great patient information site for heart disease

Im always looking for patient information sites that present material in easy way to understand for patients. As we know, its not easy to explain some of the complex issues of patient care in a brief patient interaction. I came across www.heartsite.com. They describe themselves as the online resource for reliable and unbiased information about heart disease. The site is full of information that is quite easy to understand with lots of illustrations, images and videos. Note the online lecture component. Give it a test run.