Healthcare Industry News:  neuroradiology 

Devices Interventional Ophthalmology

 News Release - August 26, 2008

Interventional Ophthalmology Procedure Indicated for Treatment of Glaucoma

Expanded 510K indication provides patients with additional surgical option to treat glaucoma.

MENLO PARK, Calif.--(HSMN NewsFeed)--Patients with glaucoma have a promising new treatment option for the reduction of elevated pressure inside the eye. Very small, complex catheters can now be inserted into small drainage structures within the eye, enabling glaucoma surgeons to enlarge these compromised outflow passages for the treatment of glaucoma. These microcatheters are measured in microns or approximately the size of four to five human hairs combined. iScience Interventional, manufacturer of these microcatheters, received expanded indications for use from the FDA for their microcatheters for specific treatment of primary open angle glaucoma (POAG). POAG is the most common form of glaucoma that occurs in approximately 90% of all glaucoma patients.

“We have been using the same surgical procedures for the last fifty years with only small modifications,” commented Richard A. Lewis, MD, past-president of the American Glaucoma Society. “Historically, we have been looking for ways to drain fluid out of the eye by using surgically created holes. A relatively new procedure known as the canaloplasty now rejuvenates the eye’s natural system to lower pressure.”

The minimally-invasive surgical technique, called the canaloplasty, uses a 250 micron microcatheter to access the drainage channels and utilizes the eye’s natural drainage system to remove fluid from the eye. This interventional procedure has been performed worldwide for more than three years.

Much like its more advanced predecessors in interventional cardiology and interventional neuroradiology, the canaloplasty is emerging into a practical alternative to more invasive surgical procedures.

“Canaloplasty strengthens the ophthalmologists’ options for patients with primary open angle glaucoma,” asserts Dr. Lewis. “Ophthalmologists have recognized for decades that the ideal solution to glaucoma would restore or maintain the eye’s natural drainage system. The canaloplasty does just that.”

Bradford J. Shingleton, MD, from the Ophthalmic Consultants of Boston and Associate Clinical Professor of Ophthalmology, Harvard Medical School added, “The canaloplasty is a procedure that is grounded in high technology and science. Over the past several years, respected researchers in Europe, Canada and the United States have amassed clinical data that support the safety and efficacy of canaloplasty for patients with POAG as well as the significant reduction of costly medications.”

For many eye surgeons and patients, canaloplasty presents the ideal treatment for POAG patients with uncontrolled eye pressure. During the 30 minute procedure, the surgeon inserts a microcatheter through a small incision, enlarges the main drainage channel and places a small suture inside the canal to maintain the opening so it can function normally. Once completed successfully, this procedure rejuvenates the native drainage system, thus lowering the pressure in the eye.

“Microcatheters represent an exciting new frontier for ophthalmology,” commented Michael Nash, President of iScience Interventional. “We believe that interventional procedures will significantly alter the treatment paradigm for a wide range of eye diseases and disorders in the future.”

Open Angle Glaucoma (OAG)

Glaucoma is a sight-threatening eye disease that affects an estimated 4 million people in the United States and 65 million people worldwide. About 120,000 Americans are blind due to glaucoma according to the Glaucoma Research Foundation. The disease is caused when the natural fluid channels (Schlemm’s canal) in the eye become blocked or clogged. This causes fluid to build up, similar to a clogged drain. When this occurs, intraocular pressure (IOP) inside the eye increases, causing permanent damage to the optic nerve. The optic nerve is essential for vision as it serves as the conduit for transmitting images and vision from the eye to the brain. There is no cure for glaucoma but its progression can be halted or slowed by lowering the pressure inside the eye.

About iScience Interventional

Since 1999, iScience Interventional has been committed to discovering and developing new microcatheter surgical-based systems for ophthalmology. By continuing to create breakthrough technologies for sight-threatening diseases, the team at iScience believes that visualization and access to compromised structures within the eye may dramatically advance how physicians evaluate and manage their patients in the future.

About 510k Clearance

The FDA has granted 510k clearance for the canaloplasty microcatheter for catheterization and viscodilation of the Schlemm’s canal to reduce intraocular pressure (IOP) in adult patients with POAG.

Source: iScience Interventional

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