Glaukos Corp. has submitted a PMA application seeking approval of its glaucoma Istent Inject trabecular micro-bypass stent. The firm's FDA submission has followed a prospective randomized trial indicating 20 percent reduction of intraocular pressure (IOP) at two years.
Prescient Surgical Inc. was awarded FDA 510(k) clearance for its surgical site infection (SSI) prevention device. The Cleancision wound retraction and protection system is designed to decrease infection during abdominal surgery.
Glaukos Corp. has reported it will initiate an IDE pivotal trial for its Istent SA trabecular micro-bypass system among pseudophakic glaucoma patients. Research will evaluate the device against selective laser trabeculoplasty (SLT) as well as safety and efficacy in reducing intraocular pressure (IOP) at one year.
Wright Medical Group NV has acquired preoperative planning software solutions provider Imascap SAS to bolster its extremities business. The sale amounted to $88.8 million (€75.1 million) made up of $46.9 million (€39.7 million) cash, $15.6 million (€13.2 million) in Wright common shares, and $26.3 million (€22.2 million) in payouts if milestones tied to software modules and a planned implant system are met.
Insightec Ltd. has closed a $150 million series E financing, led by Koch Disruptive Technologies, a Koch Industries subsidiary. Funding will be used to commercialize its MRI-guided focused ultrasound (MRgFUS) device as well as expand research into further indications.
Surgical stapler firm Dextera Surgical Inc. has voluntarily filed for bankruptcy protection and agreed to a $17.3 million asset purchase by Aesculap Inc., a B. Braun company. Financial troubles were shared in November as well as potential bankruptcy filing or sale of its assets after the company experienced raw material supply changes, resulting in backordered devices. The firm intends to resolve its backorders and continue its business relationships under Aesculap.
