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Published on 2/6/2006 in the Prospect News Biotech Daily.

Protein Polymer's new embolization kit cleared by FDA

By Lisa Kerner

Erie, Pa., Feb. 6 - Protein Polymer Technologies, Inc. said it has received 510(k) clearance from the Food and Drug Administration to market its convenience kits which are packaged with Surgica Corp.'s proprietary foam embolization products. Embolization is used to treat a variety of medical conditions including neurovascular conditions, uterine fibroids and inoperable liver cancer, according to a company news release.

The three new convenience kits have been designed to offer improved ease of use and overall procedure efficiency for physicians in the field of interventional radiology.

PVA Plus and MicroStat spherical foam embolization particles are prepackaged dry in a sterile syringe, ready for hydration and administration.

The newly developed MaxiStat particles are packaged individually, dry in a vial, hydrating almost instantly in contrast media. MaxiStat particles enable delivery of a 4 mm particle through a 0.38-inch guidewire-compatible catheter.

Protein Polymer completed a worldwide license agreement with Surgica in December, acquiring the exclusive rights to develop and commercialize PVA Plus, MicroStat and MaxiStat and one additional product under development, Blocker.

Protein Polymer is a San Diego-based biotechnology company.

Surgica manufactures and markets embolization medical devices. The company is based in El Dorado Hills, Calif.


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