Vascular Device Forum

Landmark approval for Cardiovascular risk screening test

Efforts by the Society for Heart Attack Prevention and Eradication (SHAPE) have lead to the passage of landmark legislation that requires insurers to pay for either a noncontrast CT (calcium scoring) or ultrasound to evaluate carotid intima-media thickness ratio.

Hopefully, this state legislation will be adopted nationally to the end of diminishing the number of deaths due to cardiovascular disease-the number one killer of Americans through heart attack and stroke

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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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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

The History of Angioplasty 101

The minimally invasive treatment of peripheral and coronary vascular disease is a billion dollar industry.  Lost in the current landscape of daily innovation is an appreciation of the relatively short period of time that has passed since the first coronary angioplasty in Sept 16, 1977 by Andreas Gruentzig. Angioplasty.org presents a timeline of the history of catheter based intervention.  Learn more here...

If you're a huge fan of history, you may even purchase a DVD which chronicles the process.

Finally, hear some thoughts on the evolution of angioplasty from some of the opinion leaders of interventional cardiology here

Its always amazing to learn how fast innovation accelerates after seemingly insurmountable obstacles are overcome