SAN FRANCISCO — Results from three trials evaluating Abbott Vascular's (Abbott Park, Ill.) fully absorbable stent showed non-inferiority of the device over the firm's own Xience drug-eluting stent (DES). However the data did little to provide a home run for the effectiveness of Absorb, which has yet to gain FDA approval, when the stent was compared to DES technology.
Fresh off its bid to become a public company, Novocure Ltd. (St. Helier, Jersey Isle) received FDA approval for its Optune device in combination with temozolomide to treat adult patients with newly diagnosed glioblastoma (GBM). Optune is a portable, non-invasive device that delivers low-intensity, intermediate frequency, alternating electric fields – referred to as tumor treating fields (TTF) – that inhibit cancer cell replication and cause cancer cell death.
Sanuwave Health (Alpharetta, Ga.) is still in the game after it revealed top line data from a pivotal phase III, investigational device exemption supplemental clinical trial evaluating its Dermapace diabetic foot ulcer treatment technology. While the company failed to meet its primary endpoint of healing and wound closure at 12 weeks, it did show the device had highly significant results in healing wounds at 20 weeks.
About seven months after Boston Scientific (Marlboro, Mass.) obtained approval for the Watchman left atrial appendage closure device (Medical Device Daily, March 17, 2015), the company is now reporting it has gained the FDA nod for another highly anticipated technology, the Synergy bioabsorbable polymer drug-eluting stent system (BP-DES).
Neuravi (Galway, Ireland) has launched its Embotrap revascularization device in Europe. The company joins a growing list of firms to develop stent retrieval devices, which are used in the treatment of acute ischemic stroke.
Innfocus (Miami) reported raising $32.8 million in a Series C funding round. The firm is one of several competing companies Medical Device Daily has dubbed the MIGS-6, in the minimally invasive glaucoma surgical space. The group has been highly active within the past few months, with activity that ranges from clinical trial completions to initial public offerings.
