Sientra Receives FDA Clearance for First MRI-Compatible Tissue Expander

Sientra, Inc (Nasdaq: SIEN) has received 510k clearance from the FDA for its AlloX2 Pro post-mastectomy tissue expander. AlloX2 Pro is the first and only MRI-compatible tissue expander available on the US market.

The company’s shares rose nearly 90% following the news.

Highlights

Sientra’s Allo X2 Pro builds upon the proprietary dual port technology of the company’s AlloX2® tissue expander, removing 95% of the metal traditionally associated with tissue expander ports.

The device is labeled as MRI-conditional, making it the only tissue expander cleared in the US for exposure to MRI, an important screening tool for breast reconstruction patients.

The Allo X2 Pro also offers minimal interference with radiation therapy for post-mastectomy patients, faster port filling and drainage, and a softer drain for enhanced patient comfort.

This is the third new Sientra product cleared or approved by the FDA in the past 12 months.

About Sientra

Sientra is a medical aesthetics company exclusively focused on plastic surgery. The Company mission is to offer proprietary innovations and unparalleled partnerships that radically advance how plastic surgeons think, work and care for their patients. Sientra has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. The Company’s product portfolio includes its Sientra round and shaped breast implants, the first fifth-generation breast implants approved by the FDA for sale in the United States, its ground-breaking AlloX2® breast tissue expander with patented dual-port and integral drain technology, the Viality™ with AuraClens™ enhanced viability fat transfer system, the SimpliDerm® Human Acellular Dermal Matrix, and BIOCORNEUM® the #1 performing, preferred and recommended scar gel of plastic surgeons.