Shelhigh and FDA Reach an Agreement

• On 17 April 2007 products were quarantined at the Shelhigh manufacturing facility due to questions raised during a site inspection.

• At no time during the site inspection or in the weeks afterward were any related health hazards reported to Shelhigh.

• On 19 June 2007 Shelhigh and FDA agreed to have independent experts certify Shelhigh manufacturing processes after which time FDA will verify the changes and product shipments will resume.

• FDA did not mandate nor did Shelhigh conduct a product recall at any time during or after the quarantine of 17 April 2007, and no recall is required under the terms of the June 19 agreement.

• Click here for a full press release regarding the agreement.

Interview with Dr. Marc Gerdisch on the NR2000Plus Aortic Valve

Indianapolis - A local surgeon is performing a new, life-saving heart valve procedure. Two patients, one from Ohio, the other from Chicago, came here for the procedure this week. They are participating in a clinical trial that is part of what the doctor believes is a true "next generation device" for heart patients with valve disease.

Charlie Griewe from Greensburg is in a select group of American patients. He is part of a clinical trial for a revolutionary heart valve called the Shelhigh Aortic replacement valve.

"The valve sounds perfect. You wouldn't know you had your valve replaced," said Dr. Marc Gerdisch, Cardiac Surgery Associates at St. Francis. To date, St. Francis cardiothoracic surgeon Dr. Gerdisch has implanted nearly 60 of the aortic valves.

Dr. Gerdisch says metal valves require blood thinning Coumadin for life. "Coumadin can be life saving for many people because they need it in certain situations but it also carries a significant morbidity and mortality on its own. In other words, taking Coumadin itself is a risk," said Dr. Gerdisch.

Gerdisch says calcifications are common complications of tissue valves and lead to replacements. "What we really are driving for is have a biologic valve that will last longer," he said.

Doctors like the large opening for blood to pass through and once implanted, the body seems to accept it and incorporate the valve as its own, a process called endothelization.

"There is no other valve on the planet that becomes endothelialized," said Dr. Gerdisch.

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The article above is excerpted from WTHR News; click here to access the original article.
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To learn more about the NR2000Plus valve, click here.
 

A recent publication by the German Heart Center-Berlin concludes that in patients with native and prosthetic endocarditis, the Shelhigh device shows low reinfection rate and good hemodynamics, comparable to homografts.

“Since these prostheses are readily available and their implantation straightforward, they are increasingly being used in patients with endocarditis,” the study notes.

For a copy of the full article, please go to http://www.springerlink.com/content/2u775566x0n5t7q8/fulltext.pdf.

If you experience problems with the direct link above, then go to http://www.springerlink.com/content/2u775566x0n5t7q8/ and click on Open: Entire document under the Text/PDF section in the right hand column of the page.
 

A study of 80 patients who were 80 years or older at implant of a Shelhigh aortic valve was conducted at the Department of Cardiovascular Surgery, Campus Charité Mitte, Humboldt-University, Berlin, Germany.  The study revealed low mortality and favorable hemodynamic performance. For the original reference, please go to http://www.charite.de/ch/hzchir/publ/publ06/abs0605.html
 

The Shelhigh SuperStentless^® aortic valve is in FDA clinical trials at Central DuPage Hospital in Winfield, IL under principle investigator Dr. Marc Gerdisch. Made of bovine pericardium and porcine leaflets, the valve has been approved for use in Europe, where it has been used for nine years, and has been in U.S. trials for five years.

Typical tissue valves historically have failed because the body recognizes the valve as foreign matter, and the valve slowly deteriorates. Though all other tissue valves deteriorate and calcify within a few years, no child or adult over age 80 has demonstrated tissue failure or calcification with the Shelhigh valve, according to Gerdisch. Babies usually have an accelerated calcification process, but those with the Shelhigh valve show no calcification, he said, adding, "The evidence is very strong that in an older person, the likelihood of valve deterioration is very low."

The information presented above is excepted from a Chicago Tribune article by Terri Yablonsky Stat, and may be found at...
http://www.healthdecisions.org/HealthIT/News/default.aspx?doc_id=62134

Shelhigh products may be sold only upon the written prescription of a physician. Consult Shelhigh for more information about product availability worldwide.