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news.Merz Pharma Canada, an affiliate of the global Merz Pharma Group, announced that Radiesse (+) with integral 0.3% Lidocaine (“Radiesse Plus“) has received Health Canada approval and will be available to Canadian physicians in July 2015.
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Treatment with Radiesse (+) immediately replenishes lost volume as well as providing significant reduction in pain due to the addition of lidocaine.
"With the introduction of Radiesse (+), we are proud to be able to provide physicians in Canada with a safe, effective volumizing filler that enhances patient comfort and eliminates the need for in-office lidocaine mixing," said Bob Bennett, President and General Manager for Merz Pharma Canada.
"As we continue to expand our presence in the aesthetics space, we look forward to bringing new products and additional indications to the market in order to expand the options available to our physician customers."
Radiesse (+) injectable implant is an opaque, dermal filler that contains a small quantity of local anesthetic (lidocaine).
Radiesse (+) is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for the rejuvenation of the hands. The presence of lidocaine is intended to reduce the patient’s pain during treatment.
"Merz continues to make meaningful investments in research and development programs in order to continue to bring new products to physicians and patients in North America," said David Dobrowski, Vice President and Head of North American Research and Development.
"The Health Canada approval of Radiesse (+) with integral 0.3% Lidocaine is the result of those efforts and provides an important complementary addition to our current aesthetics portfolio."
In a clinical study, 101 patients received Radiesse on one side of the face and Radiesse (+) on the other side of the face. Patients rated their pain on a scale of 0 to 10. On the scale, 0 was no pain and 10 was very severe pain.
Immediately after injection, patients rated their pain about 6.7 on a scale of 0 to 10 for the side of the face injected with Radiesse compared to about 2.3 on the same scale for the side of the face treated with Radiesse (+).
Sixty (60) minutes after treatment, patients rated their pain about 1.1 on a scale of 0 to 10 for the side of the face injected with Radiesse compared to about 0.3 on the same scale for the side of the face treated with Radiesse (+).
Radiesse (+) is an opaque dermal filler that contains a small quantity of local anesthetic (lidocaine). Radiesse (+) is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for the rejuvenation of the hands.
Radiesse (+) is composed of calcium hydroxylapatite (CaHA) microspheres suspended in a water-based gel carrier. Radiesse was first approved by Health Canada in November 2005 for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for the rejuvenation of the hand.