STAAR Surgical (STAA) FDA Advisory Panel Favorable Votes, Kips
Post# of 36
STAAR Surgical Company (STAA)
Nearsightedness, also known as myopia, is a common type of refractive error where close objects appear clearly, but distant objects appear blurry.
Phakic intraocular lenses (IOL) are new devices used to correct nearsightedness. These thin lenses are implanted permanently into the eye to help reduce the need for glasses or contact lenses.
STAA 's Visian ICL (Implantable Collamer(R) Lens) is one of the latest technological advancements in vision correction technology. It is FDA approved to correct myopia in adults ranging from -3.0D to -15.0D with less than or equal to 2.5D of astigmatism and can reduce myopia in adults ranging from -15.0D to -20.0D with less than or equal to 2.5D of astigmatism.
Astigmatism is a vision condition that causes blurred vision due either to the irregular shape of the cornea, the clear front cover of the eye, or sometimes the curvature of the lens inside the eye. An irregular shaped cornea or lens prevents light from focusing properly on the retina, the light sensitive surface at the back of the eye. As a result, vision becomes blurred at any distance.
There is no currently approved phakic IOL in the U.S. for the correction of astigmatism.
STAA reported that its Visian Toric Implantable Lens or TICL received favorable votes to three questions presented to the U.S. FDA's Ophthalmic Devices Panel of the Medical Devices Advisory Committee.
The Ophthalmic Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in the eye and makes recommendations to the Commissioner of Food and Drugs.
The Visian Toric ICL is a refractive phakic implant placed in the posterior chamber of the eye between the iris and the natural crystalline lens. It shares the same unique, foldable design as STAA 's Visian ICL. The difference between the two is the toric optical feature of the Visian Toric ICL is designed to permit the surgeon to correct both myopia and astigmatism in a single procedure.
Further, STAA was upgraded from a “hold” to a “buy” rating by brokerage firm Canaccord Genuity.
STAA designs, develops, manufactures and markets implantable lenses for the eye and delivery systems therefor. All of these lenses are foldable, which permits the surgeon to insert them through a small incision.
More about STAAR Surgical Company (STAA) at www.staar.com .
**
Crown Equity Holdings Inc. (CRWE)
CRWE is currently developing its CRWE Network ( CRWE-PR.com ), a social networking service compatible with both, the mobile and desktop web platform, that is designed to target all the communities in the U.S. and Canada, which business model is based on selling advertising to local businesses.
CRWE Network’s goal is to facilitate exchanges of goods and services in a manner similar to Craigslist, a classified advertisements website with sections devoted to jobs, housing, personals, for sale, items wanted, services, community, gigs, résumés, and discussion forums, while providing micro community news, information and business directory content.
The CRWE Network has surpassed the 150th community website, and includes coverage of the greater state of California, Northern and Southern Nevada and 9 provinces in Canada
CRWE provides marketing solutions that boost customer awareness and merchant visibility on the Internet.
More about Crown Equity Holdings Inc. (CRWE) at www.crownequityholdings.com
**
Kips Bay Medical, Inc. (KIPS)
KIPS said that the U.S. FDA has granted an approval for the company to include more U.S. patients and U.S. study sites in its "eMESH I" clinical feasibility trial of its eSVS(R) Mesh.
The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein support using KIPS ' eSVS Mesh in coronary artery bypass (CABG) surgery.
In addition, the FDA has also approved a combination of changes in the application of the eSVS Mesh to the saphenous vein graft (SVG) and to the surgical implant technique for the eSVS Mesh treated graft. The changes are intended to reduce the risk of early graft occlusion, make it easier to implant the eSVS Mesh and reduce procedural costs.
KIPS ' eSVS Mesh is designed to be fitted like a sleeve on the outside of saphenous vein grafts to strengthen SVGs used in coronary artery bypass graft surgery. By strengthening the SVG and preventing the damaging expansion of the vein graft, KIPS hopes to reduce or prevent the resulting injury which can lead to SVG failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery.
KIPS is focused on manufacturing and commercializing its external saphenous vein support technology, the eSVS Mesh, for use in coronary artery bypass grafting surgery.
More about Kips Bay Medical, Inc. (KIPS) at www.KipsBayMedical.com .
**
Read Full Disclaimer at www.pennyomega.com/disclaimer