Navigation Links
Merz Aesthetics™ Asclera™ (polidocanol) Injection Now Available in Doctors' Offices Nationwide
Date:7/15/2010

SAN MATEO, Calif., July 15 /PRNewswire/ -- Merz Aesthetics today announced it is now shipping Asclera™ (polidocanol) Injection sclerotherapy treatment to doctors' offices throughout the U.S.  Previously only available in Europe, Asclera™ was recently approved by the U.S. Food and Drug Administration (FDA).

In a study published in the June issue of Phlebology, leading experts conclude that polidocanol is a highly effective sclerotherapy treatment.

Asclera™ was approved by the FDA on March 30 to treat uncomplicated spider veins (varicose veins less than or equal to 1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremities. It has not been studied in larger varicose veins greater than 3 mm in diameter. Once injected, it acts by damaging the cell lining of blood vessels, causing them to close and eventually disappear.

Clinical support for Asclera™ continues to grow.  In the recent Phlebology study, the authors found that polidocanol demonstrated significant efficacy over other treatment options, like sodium tetradecyl sulfate (STS) 1%. In addition, patients reported better satisfaction with polidocanol than with other treatment options. Highlights from the study include:

  • The treatment success rate for polidocanol was 95% at week 12 and 95% at week 26 vs. 92% and 91% for STS, respectively; both were significantly higher than placebo (P< 0.0001).
  • The majority of patients treated with polidocanol were satisfied with the treatment.
    • 87% at week 12 and 84% at week 26 for patients treated with polidocanol
    • 64% at week 12 and 63% at week 26 for patients treated with STS
    • 14% at week 12 and 16% at week 26 for patients treated with placebo
  • Treatment with polidocanol was safe and, apart from local "mild"-to-"moderate" symptoms at the injection site, well tolerated.

"The arrival of Asclera™ has been highly anticipated among physicians, with very positive initial reactions and the number of pre-orders exceeding our expectations," said Dennis Condon, President of BioForm Medical, Inc., a Merz Aesthetics company. "We are proud to finally deliver the next level of cosmetic procedure performance that physicians and patients demand."

Asclera™ will be shipped to doctors' offices nationwide no later than July 15th.  For more information and to find a doctor near you who uses Asclera™, visit www.Asclera.com.  

Important Safety Information:

Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are more frequent with use of larger volumes (>3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately.

Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, take care in intravenous needle placement and the smallest effective volume at each injection site should be used.

After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes.  Keep the patient under supervision during this period to treat any anaphylactic or allergic reaction, should one occur.

Intra-arterial injection can cause severe necrosis, ischemia or gangrene.  If this occurs, consult a vascular surgeon immediately.

Inadvertent perivascular injection of Asclera™ can cause pain.  If pain is severe, a local anesthetic (without adrenaline) may be injected.

In clinical studies the following adverse events were observed after using Asclera™:  injection site haematoma, injection site irritation, injection site discoloration, injection site pain, injection site pruritus, injection site warmth, revascularization, injection site thrombosis.

Asclera™ is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.  

Please click here for the full prescribing information on Asclera™ (polidocanol) Injection.

About Merz Aesthetics

Merz Aesthetics, the new business unit of Merz Pharma Group, is a leader in the global aesthetic medicine market.  With a 100-year history of compassion and innovation in healthcare, Merz Aesthetics is committed to delivering a new generation of aesthetic care.  

BioForm Medical, Inc. is a wholly-owned subsidiary of Merz, Inc.  Headquartered in San Mateo, California, BioForm Medical, Inc. is focused on developing products that enhance aesthetic procedures performed in dermatology and plastic surgery practices. BioForm Medical's lead product is RADIESSE® dermal filler, a long-lasting filler for use in facial aesthetics.


'/>"/>
SOURCE Merz Aesthetics
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints
2. Study Shows Vasopressin Receptor Antagonist VAPRISOL(R) (Conivaptan Hydrochloride Injection) Significantly Increased Serum Sodium Concentration in Patients with Euvolemic & Hypervolemic Hyponatremia
3. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
4. Analysis Shows Vernakalant Hydrochloride Injection Increases Conversion to Normal Heart Rhythm in Acute Atrial Fibrillation Patients Treated Within 48 Hours of Onset
5. New Data to Support VELCADE(R) (Bortezomib) For Injection Based Therapies as Setting New Standards in The Care of Newly Diagnosed Patients With Multiple Myeloma
6. Isolagen Inc. Completes Injections of Isolagen Therapy(TM) in Phase III Wrinkle and Phase II Full Face Studies
7. FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
8. Millennium Expands VELCADE(R) (Bortezomib) For Injection Program In Non-Hodgkins Lymphoma
9. Inclusion of Six-Year Overall Survival Data in the Eloxatin(R) (oxaliplatin injection) Prescribing Information Granted FDA Priority Review
10. Circulation Publishes Data Showing KYNAPID(TM) (Vernakalant Hydrochloride) Injection Rapidly Converted Short-Duration Atrial Fibrillation to Sinus Rhythm
11. CorMatrix(R) Announces Intramyocardial Injection of Emulsified ECM Technology(TM) Demonstrates Enhanced Angiogenesis and Improved Cardiac Function in a Preclinical Model
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... 25, 2016  Zymo Research Corp. announced today ... reference materials that help researchers obtain the most ... analyses. The rapid growth of the study of ... have standard methods to improve the reproducibility and ... exist at every step of the measurement process ...
(Date:5/25/2016)... Digital Health Dialog, LLC dba EngagedMedia ... US Patent and Trademark Office of U.S. Patent ... for electronic opt-­in and processing of discount coupons ... compliance and otherwise. Logo - http://photos.prnewswire.com/prnh/20160524/371583LOGO ... "Our technology allows for individuals to opt­-in to ...
(Date:5/24/2016)... 2016 Cirujanos holandeses han puesto ... los médicos a compartir sus mejores prácticas por el ... Profesionales médicos de Europa, África, Asia ... la aplicación, que combina la transmisión en vivo con ... Educación   "Imagine un médico de ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... 26, 2016 , ... W.S. Badger Co. Inc ., the maker of ... When Work Works Award for its use of effective workplace strategies to increase business ... project administered by the Families and Work Institute (FWI) and the Society for Human ...
(Date:5/26/2016)... ... May 26, 2016 , ... Connor Sports, through its Connor Cares ... the Tamika Catchings Legacy Tour that will commemorate the Indiana Fever legend’s ... surfaces in all forms and levels of the game, Connor Sports has committed to ...
(Date:5/26/2016)... ... ... There are nearly 14.5 million people living with and beyond cancer in ... 5, 2016, communities around the world will gather to recognize these cancer survivors as ... Day® is an annual worldwide Celebration of Life that is held on the first ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... An April ... American families. , The 550 employees of Sun Health Senior Living (SHSL) ... Aetna that reduces their doctor and prescription copays for the year, while holding the ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... treatment for eating disorders, is opening a brand new child and adolescent residential ... 8-17 and their families with even more specialized eating disorder treatment and access ...
Breaking Medicine News(10 mins):