TOPIC: Ellanse

ellanse.com

EU Approved and FDA Approval expected 2012

Long term results and absorbable

Collagen stimulator (like pmma)

Looks decent. Pardon the bad cut and paste


FAQ's

What is the difference between Ellans' and other dermal fillers?
The unique advantages of Ellans' are Sustained Performance, Tunable Longevity and Total Bioresorbability. Unlike other dermal fillers, Ellans' offers a complete customized solution for patients seeking longer-lasting results.

What is the specific difference between Ellans' and hyaluronic acid (HA) fillers?
The optimum combination of high viscosity and unique elasticity distinguishes Ellans' from the more fluid and short-lasting HA-fillers, and provides a better filling and lifting effect, and targeted placement. In addition, Ellans' stimulates the generation of new collagen giving a high quality sustained performance, in comparison to HA-fillers. Moreover, Ellans' is more cost-effective as less volume is required for the desired aesthetic results.

What is the specific difference between Ellans' and other particle fillers?
Ellans' is a non-permanent, safe and proven totally bioresorbable dermal filler in a ready for use syringe and primarily consists of soft smooth spherical shaped microparticles specifically designed for optimal biocompatibility. Ellans' is clearly differentiated by the unique features of Immediate and Sustained Performance, Tunable Longevity and predictable and controlled Total Bioresorbability.

What is the specific difference between Ellans' and permanent fillers?
Ellans' is not a permanent dermal filler. Total Bioresorbability of Ellans' is extensively tested and proven.

Is a allergy test required?
No, Ellans' is a non-animal, non-bacterial and non-human derived product which eliminates the need of an allergy test.

Is degradation the same as Total Bioresorbability?
No. Degradation is sometimes mistakenly equated with bioresorbability. Total Bioresorbability means that Ellans' is completely removed from the body with no residues of any kind left behind. In comparison, degradable materials may still leave fragmented product and/or degradation products in the body for many years or even permanently, which might lead to late inflammatory complications.

How should Ellans' be stored?
Ellans' can be stored at room temperature (15 ' 25'C ) in its original sealed packaging. Ellanse' must be used prior to the expiration date printed on the package. Do not freeze, and protect from sunlight.

What is the regulatory status of the Ellans' Family?
The entire Ellans' Family is CE-marked and therefore its safety and performance are approved. Ellans' is in compliance with the highest European safety standards for Implantable Medical Devices. AQTIS Medical' is an ISO-13485 certified manufacturer and operates according to the highest international quality assurance guidelines.

What is the Ellanse' family?
Ellans' is a unique dermal filler family, which is specifically designed and offers a Total Customized Solution for patients seeking longer-lasting results in medical aesthetics. It is the first dermal filler family with the unique feature of Tunable Longevity. Ellans' is further differentiated by the characteristics of Sustained Performance and Total and Controlled Bioresorbability (STAT' Technology'). The four options Ellans'-S, Ellans'-M, Ellans'-L, and Ellans'-E differ from each other only in their duration of performance, which ranges from 12 months up to 4 years or more.
Another unique advantage of the Ellans' Family is the identical injectability and lifting effect for all four duration options, as the visco-elastic properties are the same. This means that the needle size is independent of the selected duration option.

What are the components of Ellanse'?
Ellans' is a safe and clinically proven synthetic dermal filler, composed of totally smooth Polycaprolactone (PCL) microspheres, homogenously suspended in an aqueous Carboxymethyl cellulose (CMC) gel'carrier.
PCL is a well-known totally bioresorbable soft medical material, used in numerous CE-marked and Food and Drug Administration (FDA) approved commercial bioresorbable medical device applications like e.g. biodegradable sutures and orthopedic implants, for several decades world-wide and has demonstrated an excellent safety profile.
CMC has been used in numerous CE-marked and Food and Drug Administration (FDA) approved commercial product applications in medical, cosmetic and pharmaceutical industries e.g. dermal fillers, oral and maxillo-facial surgery, for several decades worldwide and has demonstrated an excellent safety profile.

Who makes Ellanse'?
Ellanse' is manufactured by AQTIS Medical', a Dutch-based privately-held medical device company, which specializes in the research and development, manufacturing and commercialization of innovative injectable medical devices.
Which are the indications for use of Ellanse'?
The indications for Ellanse' can be found here: Ellanse' indications

How to use Ellanse'?
Ellanse' is to be injected into the deep dermal tissue near the subdermal junction. The recommended needle size for Ellanse' is 27 ' 30G.
Are there any side effects or adverse reactions?
Common and expected injection-related side effects like swelling, redness and bruising might occur. These side effects generally last 1-2 days and are mild in nature.

Is the safety of Ellanse' clinically proven?
The safety and efficacy of the Ellans' dermal filler family is being studied through a two-year, prospective, randomized clinical study, which is ongoing at Hautok clinic, Germany (initiated December 2008). The study is conducted in accordance with ISO standard 14155 and the ICH GCP standard E6. The 18 month data demonstrate an excellent safety and performance profile. Further clinical studies for ongoing clinical research activities and new indications will be conducted in order to even further evidence the uniqueness and advantages of Ellans'.

Are the results immediate?
The results are immediately visible after injection and are sustained and longer-lasting, but non-permanent in comparison to other dermal fillers, due to the specifically unique designed visco-elastic properties.

Wat is recommended after treatment?
Application of ice or cool compresses to areas of injection is recommended. The patient should be informed to minimize exposure of the treated area to excessive Sun- or UV-light until any initial redness or swelling has resolved.

How does Ellans' work?
Ellans' is a collagen stimulator, due to its unique elasticity characteristics and safe performance. Ellans' stimulates the body to generate new collagen (neo-collagenesis) which gives the patient a desired, youthful and natural looking appearance

Zol,

Nice find! I wonder how much this stuff is going to cost?

I\'ll be keeping an eye out for this, might make a good glans enhancement material possibly.