FDA Approvals: Prosthetic Titanium Rib Implant, Clarinex, Peripheral Cutting Balloon, and Others
Sept. 7, 2004 — The U.S. Food and Drug Administration (FDA) has approved an implantable metal rod for children with thoracic insufficiency syndrome, desloratadine for pediatric use, a heel-stick test for congenital metabolic diseases in newborns, a microsurgical dilatation device for use in hemodialysis grafts, and a new formulation for digoxin.
Implantable Metal Rod (Vertical Expandable Prosthetic Titanium Rib) for Children With Thoracic Insufficiency Syndrome
On Sept. 2, the FDA approved a humanitarian device exemption (HDE) for an implantable metal rod device (Vertical Expandable Prosthetic Titanium Rib, made by Synthes Spine Corp., the U.S. division of Synthes-Stratec), to correct chest wall instability in pediatric patients aged six months to vertebral maturity (14 years in girls, 16 years in boys) with thoracic insufficiency syndrome caused by severe deformities of the chest, spine, and ribs.
The curved metal rod is attached by hooks at both ends to ribs near the spine. By straightening the spine and separating the ribs, the device allows expansion of the chest cavity for breathing and lung development. The implanted device must be lengthened or replaced every six months as the patient matures.
The approval was based on the results of a study involving 147 pediatric patients aged six months to 15 years with serious defects such as scoliosis. The study demonstrated the device to be safe and of probable benefit in enabling unassisted breathing and less dependence on ventilators in some patients. Without treatment, children with the syndrome risk death from respiratory infections or inability to breathe. Twelve deaths during the study were not associated with use of the device.
An HDE is an approval for a device of probable benefit in diagnosing or treating patients with a rare medical condition affecting fewer than 4,000 people in the U.S. each year.
Desloratadine (Clarinex) for Pediatric Use
On Sept. 2, the FDA approved a new syrup formulation for desloratadine (Clarinex, made by Schering-Plough Corp.), indicated for the relief of symptoms associated with seasonal allergic rhinitis in children aged two years and older, and perennial allergic rhinitis, chronic idiopathic urticaria (CIU), or hives of unknown cause in children aged six months and older.
The approval was based on the results of three double-blind, placebo-controlled studies involving 246 patients aged six months to 11 years, which demonstrated desloratadine's safety in children with documented history of allergic rhinitis, CIU, or other conditions requiring antihistamine therapy. Adverse events were similar with desloratadine compared with placebo and included upper respiratory tract infection, diarrhea, fever, urinary tract infection, varicella, irritability, and coughing.
Lab Test Screens Newborn Infants for Congenital Metabolic Diseases
On Aug. 25, the FDA approved a heel-stick laboratory test (NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, made by PerkinElmer Life and Analytical Sciences, Inc.) for use in screening newborn infants against a variety of congenital metabolic diseases.
The test screens a newborn's blood for elevated or abnormal patterns in levels of amino acids, free carnitine, and acylcarnitines that may indicate a risk of phenylketonuria, maple syrup urine disease, medium-chain Acyl-CoA dehydrogenase deficiency, isovaleric acidemia, homocystinuria, hereditary tyrosinemia, or other inborn errors of metabolism.
Results of the screening are combined with a clinical evaluation to determine the newborn's risk of these diseases that are individually rare, yet common as a group. Early diagnosis can improve long-term outcome and quality of life by significantly reducing such effects as developmental delay, seizures, mental retardation, and death.
Device (Peripheral Cutting Balloon) Dilates Lesions at Lower Pressures Than Angioplasty
On Aug. 25, the FDA approved a microsurgical dilatation device (Peripheral Cutting Balloon, made by Boston Scientific Corp.) for use in treating graft stenosis in patients undergoing hemodialysis for end-stage renal disease.
The device features tiny, longitudinally mounted microsurgical blades (atherotomes) that score the lesion with precise incisions as the balloon is expanded, allowing vessel dilation with less barotrauma than conventional percutaneous transluminal angioplasty. Scoring also disrupts the elastic and fibrotic continuity of the lesion and prevents elastic recoil.
According to a company news release, the device is associated with reduced patient pain and a six-month benefit to patients with thrombosed dialysis grafts. It can be used as stand-alone treatment or in conjunction with other treatment options. The device has been used in Europe and Japan for more than a decade.
Digoxin 0.05 mg/mL Elixir for Heart Failure and Atrial Fibrillation
On Aug. 26, the FDA approved a new elixir formulation for digoxin (Digoxin 0.05 mg/mL Elixir, made by Roxane Laboratories) for use in the treatment of heart failure and atrial fibrillation. Digoxin was previously available in tablets, capsules, and by injection.
Reviewed by Gary D. Vogin, MD
This is a part of article FDA Approvals: Prosthetic Titanium Rib Implant, Clarinex, Peripheral Cutting Balloon, and Others Taken from "Generic Clarinex (Desloratadine) Page" Information Blog