Truliant porous 3D tibial implant

AMStent Tracheobronchial Covered Stent System

The U.S. Food and Drug Administration (FDA) has granted marketing authorization (clearance to market in the United States as a Class II device) for Peytant Solutions Inc.’s AMStent Tracheobronchial Covered Stent System. The AMStent System, a novel, proprietary therapy platform, is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms in adult patients.

The AMStent System is the first product offering within Peytant’s amnion-based covered stent platform. The system combines a minimally invasive catheter delivery system with a stent covered in a material created from amnion. Amnion has more than 100 years of clinical history, first as a transplant for eye surface reconstruction, and more recently as a therapeutic membrane for the treatment of chronic wounds and skin ulcers.

The AMStent System is designed to treat pulmonary obstructions caused by cancer. The benefits of the AMStent System, as seen in validation data, include reduced migration, reduced local inflammation and granuloma formation, and reduced mucus accumulation and occlusion.

Peytant is the pioneer in the development of human amnion-based covering for stents. https://www.peytant.com

LinkSymphoKnee implants with TMINI miniature robotic system

THINK Surgical’s TMINI Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with the LinkSymphoKnee (LSK) from Waldemar Link GmbH & Co. KG, Germany (LINK) under a collaboration agreement between the two companies.

The LinkSymphoKnee has been added to THINK Surgical’s ID-HUB, a proprietary data bank of implant modules for use with the open platform version of its TMINI System in the United States. https://thinksurgical.com

Truliant porous 3D tibial implant

Exactech received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Truliant Porous Tibial Tray, a 3D tibial knee implant. The Truliant Porous Tibial Tray leverages additive manufacturing (AM) technology to create a porous structure designed to mimic the structure of cancellous bone. This design aims to facilitate initial and biological fixation to accommodate patients’ active lifestyles.

Exactech’s Truliant porous laser-printed 3D tibial tray features peripherally placed tibial pegs, a dual V-channeled keel and optional cancellous bone screws designed to increase initial rotational stability and allow an increased bone-implant interface. https://www.exac.com