Raven Medicals is a rapidly growing company that was established in 2000 by CEO Joel Kale. It has its headquarters in Waltham, Massachusetts and currently employs around 2000 individuals. It has a laboratory space in Waltham, Massachusetts and a manufacturing plant in Foxborough, Massachusetts that follows GMP procedures and ISO 9001:2015, ISO 13485:2016. Raven Medicals have a range of medical devices in market such as surgical products, orthopaedic implants and surgical sealants. It is now coming up with a new medical device, ViStent, a microtubular stent for treating glaucoma, within the ophthalmic sector. Raven Medicals plans to submit their Pre-Market Approval (PMA) application to FDA by March 2019 and subsequently spread their market into
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If left untreated, it may also lead to permanent loss of vision and eventual blindness. Glaucoma can affect any age group. However, it is more prevalent amongst the geriatric population. The primary cause of optic nerve damage is the increased pressure in the eyeball. This rise in pressure is due to accumulation of aqueous humor, which is generally expected to get drained into the anterior chamber of the eye. Overproduction of the fluid or failure in the draining system results in increased pressure in the eyeball which subsequently damages the optic nerve and thus glaucoma.
Speaking of global statistics, a recent study shows that glaucoma rate is Canada is 1.9% more prevalent than USA. More than 400,000 Canadians suffer from glaucoma . In Mexico, the glaucoma rate has increased by 13.3% since 1990 and is the most common ophthalmic disorder amongst its population. The numbers with Japan is quite disturbing. Japan projects an increased glaucoma rate of 72.6% since 1990 with an average of 3.2% per year. More than half of the Japanese population suffer from glaucoma . Hence, based on these statistics, Canada, Mexico and Japan would be the target countries for Raven Medicals’ …show more content…
• Device Description
The ViStent, is a single piece, L-shaped structure made up of titanium. It is provided in form of two models, VSL for the left eye and VSR for the right eye. It is dispensed pre-stacked with a single use tool (inserter) for introducing into the eye during a cataract surgery. Once inside the eye, the inserter is passed over the foremost chamber and embedded through the nasal trabecular meshwork into the Schlemm's canal. On appropriate implantation, the stent is bypassed through the trabecular meshwork to Schlemm's canal to enhance watery surge through the common physiologic pathway.
The stent is 1.0 mm x 0.30 mm with a snorkel length of 0.20 mm, and a snorkel bore measurement of 100pm. The stent has a "L"- formed structure with a snorkel (channel) on the short side that lies in the anterior chamber, the half-pipe side of it opens in Schlemm's canal. The closed-pipe body resides against the internal wall of Schlemm's canal. The open half-pipe body portion resides against the outer wall of Schlemm’s canal and serves as collector channels. The device is coated with heparin to provide lubrication to the device during the initial
If left untreated, it may also lead to permanent loss of vision and eventual blindness. Glaucoma can affect any age group. However, it is more prevalent amongst the geriatric population. The primary cause of optic nerve damage is the increased pressure in the eyeball. This rise in pressure is due to accumulation of aqueous humor, which is generally expected to get drained into the anterior chamber of the eye. Overproduction of the fluid or failure in the draining system results in increased pressure in the eyeball which subsequently damages the optic nerve and thus glaucoma.
Speaking of global statistics, a recent study shows that glaucoma rate is Canada is 1.9% more prevalent than USA. More than 400,000 Canadians suffer from glaucoma . In Mexico, the glaucoma rate has increased by 13.3% since 1990 and is the most common ophthalmic disorder amongst its population. The numbers with Japan is quite disturbing. Japan projects an increased glaucoma rate of 72.6% since 1990 with an average of 3.2% per year. More than half of the Japanese population suffer from glaucoma . Hence, based on these statistics, Canada, Mexico and Japan would be the target countries for Raven Medicals’ …show more content…
• Device Description
The ViStent, is a single piece, L-shaped structure made up of titanium. It is provided in form of two models, VSL for the left eye and VSR for the right eye. It is dispensed pre-stacked with a single use tool (inserter) for introducing into the eye during a cataract surgery. Once inside the eye, the inserter is passed over the foremost chamber and embedded through the nasal trabecular meshwork into the Schlemm's canal. On appropriate implantation, the stent is bypassed through the trabecular meshwork to Schlemm's canal to enhance watery surge through the common physiologic pathway.
The stent is 1.0 mm x 0.30 mm with a snorkel length of 0.20 mm, and a snorkel bore measurement of 100pm. The stent has a "L"- formed structure with a snorkel (channel) on the short side that lies in the anterior chamber, the half-pipe side of it opens in Schlemm's canal. The closed-pipe body resides against the internal wall of Schlemm's canal. The open half-pipe body portion resides against the outer wall of Schlemm’s canal and serves as collector channels. The device is coated with heparin to provide lubrication to the device during the initial