April 19, 2007 — Following Tuesday’s seizing of all implantable medical devices from Shelhigh Inc., Union, NJ, by FDA investigators and U.S. marshals, the company has responded with denials to FDA claims that its manufacturing processes that may compromise the safety and effectiveness of the products, particularly their sterility. Shelhigh will challenge the decision in Federal Court (07 Civ 1769 WJM, New Jersey).
"I am deeply disappointed by the FDA decision which was made after the full cooperation of Shelhigh during an intensive 10 week inspection of our facility by the FDA," said Shelhigh founder and chief scientific officer, Shlomo Gabbay, M.D. "During this inspection Shelhigh fully addressed all observations raised by FDA personnel, repeatedly requested corrections of statements made by the FDA in their site report, and also repeatedly requested meetings with the FDA to discuss any outstanding issues as well as concerns which arose during the 10 week inspection, and these meetings were also refused by the FDA."
The FDA press release, which was issued the same day the seizure began, also noted that critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.
"These are the very same patients that Shelhigh products have been helping over the past 10 years, extending their lives often when no other solution was available to them, " Dr. Gabbay responded.
Shelhigh No-React products are acknowledged in peer-reviewed scientific journals as offering unique resistance to infection, even in cases of active infective endocarditis (AIE).
Asked about the FDA reference to two warning letters, Dr. Gabbay replied that the first warning letter was from 2000 and all FDA opinions expressed in that letter were addressed, and that the second warning letter issued in 2005 was the one for which Shelhigh has sought verification pertaining to the actions implemented by Shelhigh.
"I can't explain why the FDA sometimes chooses to ignore factual information but it does happen," said Dr. Gabbay. "It is unfortunate that the FDA is stopping Shelhigh from shipping our life-saving products, and I remain hopeful that the FDA will quickly resolve whatever internal issues they have which have lead to their baffling seizure decision," said Dr. Gabbay.
Medical devices manufactured by Shelhigh include:
* Shelhigh Pericardial Patch
* Shelhigh No-React Pericardial Patch
* Shelhigh No-React PneumoPledgets
* Shelhigh No-React VascuPatch
* Shelhigh No-React Tissue Repair Patch/UroPatch
* Shelhigh Pulmonic Valve Conduit No-React Treated
* Shelhigh No-React Dura Shield
* Shelhigh BioRing (annuloplasty ring)
* Shelhigh No-React EnCuff Patch
* Shelhigh No-React Stentless Valve Conduit
* Shelhigh Internal Mammary Artery
* Shelhigh Gold perforated patches
* Shelhigh Pre Curved Aortic Patch (Open)
* Shelhigh NR2000 SemiStented aortic tricuspid valve
* Shelhigh BioConduit stentless valve
* Shelhigh NR900A tricuspid valve
* Shelhigh MitroFast Mitral Valve Repair System
* Shelhigh BioMitral tricuspid valve
* Shelhigh Injectable Pulmonic Valve System