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:7/31/2017)... 2017 Three Tru-D SmartUVC robots have arrived at ... . Tru-D, short for "Total Room Ultraviolet Disinfection," is a 5-foot-5 ... environmental services (ES) professional cleans the area with traditional cleaning protocols. ... Tru-D fights germs at ... "Although the BAACH has a very low ...
(Date:7/27/2017)... 27, 2017  Zimmer Biomet Holdings, Inc. (NYSE and ... June 30, 2017.  The Company reported second quarter net ... the prior year period, and an increase of 2.1% ... points of contribution from the LDR Holding Corporation acquisition, ... quarter of 2016, or 0.3% on a constant currency ...
(Date:7/26/2017)... 26, 2017 Sancilio Pharmaceuticals Company, Inc. (SPCI) ... trial evaluating Altemia TM , an oral therapy for ... Cell Disease (SCD). The SCOT Trial, is a double-blind, ... safety of Altemia TM in pediatric patients aged ... IND 125274. "The ...
Breaking Medicine Technology:
(Date:8/22/2017)... ... August 22, 2017 , ... Five Star Glass is new to the Texas market, but ... of auto glass for most makes and models, in Grand Prairie, TX, located in the ... They have been a family owned business for the past 40 years with 32 convenient ...
(Date:8/22/2017)... ... , ... “Glimpses Of Light”: is a unique and thought inspiring guide ... creation of published author, J.M. Shepherd, a writer, teacher, traveler, and metaphysician, the author ... , Shepherd shares, “Love is one of the least understood and yet most sought-after ...
(Date:8/21/2017)... MO (PRWEB) , ... August 22, 2017 , ... PracticeMatch, ... fairs to help healthcare employers connect with physicians and advanced practitioners like nurse ... virtual career fairs in August through November of this year. The online career ...
(Date:8/21/2017)... ... 2017 , ... SportsEngine, Inc. , a division of ... of North Country Region Volleyball and will power registration, scheduling, and competition results ... sport management software to their member clubs. , SportsEngine provides financial ...
(Date:8/21/2017)... ... , ... PIXACORE , an independent full-service agency with a decade of ... the year by MM&M. , This is the first time PIXACORE has made the ... agency. PIXACORE’s newfound recognition reflects its steady trajectory of growth and recent strategic ...
Breaking Medicine News(10 mins):