LensAR™ Laser System Receives FDA Clearance For Lens Fragmentation And Anterior Capsulotomy In Cataract Surgery

Main Category: Eye Health / Blindness
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
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LensAR, Inc., the leading developer of next-generation laser technology for refractive cataract surgery, announced that the company has received 510(k) clearance from the FDA for use of the LensAR™ Laser System for anterior capsulotomy and lens fragmentation during cataract surgery.

"Receiving the additional FDA indication for lens fragmentation is a significant milestone achievement in getting our technology one step closer to commercialization. We are very pleased with the exceptional fragmentation data that was submitted to obtain the indication and the resulting FDA clearance," said Randy Frey, founder and Chief Executive Officer of LensAR™.

Louis "Skip" Nichamin, MD, went on to comment, "In 2010, I was honored to be the first US surgeon to use the LensAR™ Laser System. I found that even in the most advanced grades of cataract that the lens fragmentation and extraction process was considerably more proficient and seamless than conventional phacoemulsification. The recent FDA clearance is a tremendous accomplishment in advancing innovative technologies that will improve lens replacement surgery."

The LensAR™ Laser System has been developed to meet the advancing needs of refractive cataract surgeons and their patients. The proprietary 3D-CSI™ (Confocal Structured Illumination) imaging and biometry system is being designed to image and analyze the anatomy across all grades of cataract to improve proficiency.

Unlike traditional imaging systems, 3D-CSI™ provides clean, low noise images that are both high contrast and high-resolution from the anterior surface of the cornea to the posterior capsule. The precision of the LensAR™ Laser System creates an exact capsulotomy incision size and placement based on IOL selection and fragments high grade cataracts for easier removal.

The LensAR™ Laser System is cleared by the FDA for anterior capsulotomy and lens fragmentation. The system has been used in more than 500 eyes outside the United States to date. For other indications it is an investigational device limited by US law to investigational use only.

Source:
LensAR, Inc.

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New Brain Drug Delivery System Will Help Alzheimer's Patients

Editor's Choice
Main Category: Alzheimer's / Dementia
Also Included In: Neurology / Neuroscience
Article Date: 21 Mar 2011 - 10:00 PDT window.fbAsyncInit = function() { FB.init({ appId: 'aa16a4bf93f23f07eb33109d5f1134d3', status: true, cookie: true, xfbml: true, channelUrl: 'http://www.medicalnewstoday.com/scripts/facebooklike.html'}); }; (function() { var e = document.createElement('script'); e.async = true; e.src = document.location.protocol + '//connect.facebook.net/en_US/all.js'; document.getElementById('fb-root').appendChild(e); }()); email to a friend   printer friendly   opinions

One of the medical challenges with diseases of the brain is getting any treatment to cross the blood-brain barrier, however tests on the brains of mice with Alzheimer's traits, has shown it is possible to use the body's own natural delivery system to get manufactured treatments absorbed by the brain.

Dr. Matthew Wood stated in the research:

"These are dramatic and exciting results. This is the first time this natural system has been exploited for drug delivery. We are working on sending exosomes to muscle, but you can envisage targeting any tissue. It can also be made specific by changing the drug used."

Currently, less than 5% of drugs (made up of very small molecules) are able to cross the barrier; one example is temozolomide, which is the only chemotherapy available for treating brain tumours such as glioblastoma multiforme and progressive anaplastic astrocytoma. These tumours have a poor prognosis and continue to grow, even after treatment with temozolomide. Therefore, new therapies for these hard-to-treat brain tumours are needed urgently alongside brain malfunctions such as Alzheimer's, Parkinson's and more.

This natural barrier exists to protect the brain, preventing bacteria from crossing over from the blood, while letting oxygen through. However, this has also produced problems for medicine, as drugs can also be blocked. Researchers used the body's own transporters, exosomes, to deliver drugs and proved to be quite successful.

The team at Oxford harvested exosomes from mouse dentritic cells, part of the immune system, which naturally produce large numbers of exosomes. They then fused the exosomes with targeting proteins from the rabies virus, which binds to acetylcholine receptors in brain cells, so the exosome would target the brain.

They filled the exosomes with a piece of genetic code, siRNA, and injected them back into the mice. The siRNA was delivered to the brain cells and turned off a gene, BACE1, which is involved in Alzheimer's disease.

The authors reported a 60% reduction in the gene's activity.

This could be a groundbreaking advancement in the treatment of debilitating Alzheimer's disease and thought leaders on the subject are excited by these new studies. Dr. Susanne Sorensen, head of research at the Alzheimer's Society, said:

"In this exciting study, researchers may have overcome a major barrier to the delivery of potential new drugs for many neurological diseases including Alzheimer's. The blood-brain barrier had been an enormous issue as many potential drugs have not been properly tested because you couldn't get enough of them into the brain. If this delivery method proves safe in humans, then we may see more effective drugs being made available for people with Alzheimer's in the future."

Dr Simon Ridley, head of research at Alzheimer's Research UK, adds: "This is innovative research, but at such an early stage it's still a long way from becoming a treatment for patients. Designing drugs that cross the blood brain barrier is a key goal of research that holds the promise of improving the effectiveness of Alzheimer's treatments in the future."

Source: Nature Biotechnology

Written by Sy Kraft, B.A.
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

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