E-Articles - Health and Fitness

Improvisation is the key to better performance always, and this holds good for lasik surgery too. Over the years, scientists have been looking at ways and means

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

to improve the quality of lasik surgery.

The surgery has involved two steps: cutting open a flap of the cornea and then making the required adjustment. Usuall

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

y, the cornea is cut using a hand held device called a microkeratome having an oscillating metal blade.

With the invention of the IntraLase method, this incons

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

istency is now taken out of the equation. The IntraLase method, also commonly called 'bladeless lasik', is a breakthrough innovation in lasik surgery.

The Intr

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

aLase method takes away the need for a handheld blade during the surgery. The hand-held microkeratome while being extremely useful, came with its own set of pro

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

blems.

While this process has been relatively safe, the one area where it has failed to deliver is the ability to provide consistency in depth and thickness wh

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ile making an incision. This is primarily because of the inconsistency in the precision levels provided by the microkeratome. Besides there have been other risk

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

areas, such as the flap being too thin, often leading to a tear in the flap, or the flap not being cut out entirely.

IntraLase is a computer-controlled techno

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

logy used in lasik surgery that enables a surgeon to cut through the corneal surface and create the required flap with utmost accuracy and precision.

It delive

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

rs pulses of light in rapid succession, at intervals of one quadrillionth of a second to a specific depth. The depth to which the pulses are to be delivered can

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

be fixed prior to the procedure itself, as also the position at which the flap is to be made.

IntraLase is the first of its kind used for lasik surgery, and th

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

e bladeless aspect of the procedure is a big plus for surgeons looking for the right depth and positioning.

While a microkeratome can create a cut that is one-

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

dimensional, the IntraLase technology enables surgeons to detail all the specific aspects of the flap – the thickness of the flap, the exact location on the cor

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

nea where it is to be created, the circumference of the flap, the angles of the edges of the flap.

This possibility enables surgeons to provide highly specific

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

flaps for each patient, something that was not possible with the microkeratome. This is a huge advantage over other existing procedures of lasik surgery, as it

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

increases manifold the accuracy and specificity of individual procedures for different patients.

The wide acceptance of this new technology of lasik surgery i

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

s evident from the numbers – over 1,000,000 surgeries have been performed to date using the IntraLase method.

One of the greatest advantages of the IntraLase i

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

s consistency in the positioning and dimensions of the flap. The second major advantage is that there is no physical contact of a blade with the eye; the cut is

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

done using a laser.

There are considerably lesser side effects, with patients reporting reduced instances of inability to see well in places having a low ligh

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

t source. Besides, a corneal flap created using the IntraLase method of lasik surgery ensures that the flap falls back in the exact location after the procedure

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.e-article.org.ua/article/246438/e-article-A-Better-Option-for-Lasik-Surgery-The-IntraLase-Method.html">A Better Option for Lasik Surgery: The IntraLase Method</a>

BB link (for phorums):
[url=http://www.e-article.org.ua/article/246438/e-article-A-Better-Option-for-Lasik-Surgery-The-IntraLase-Method.html]A Better Option for Lasik Surgery: The IntraLase Method[/url]

Are you a wealthy individual looking to make your budget for overseas property go further, or someone who thinks that owning a holiday property is an impossible dream? In either case, with the power of fractional ownership you can make it happen says Neil Robertson.

The worst condition is keeping a fully charged battery at elevated temperatures, which is the case when running a battery powered device on AC power for extended periods of time. If used on main power, the battery inside a device will only last for 12-18 months. Also the battery will not all of sudden stop working but over time gradually lose the capacity to power your device little by little.

Tags

Links

E-Articles - A Better Option for Lasik Surgery: The IntraLase Method

Related Articles: