Urotronic announced that the FDA approved its Optilume BPH catheter system for to alleviate urinary symptoms caused by BPH. Minneapolis-based Urotronic designed Optilume as a minimally invasive surgical therapy. It combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel. This treats lower urinary tract symptoms secondary to BPG (benign prostatic […]
Catheters
FDA updates guidance on paclitaxel-coated devices, determines no link to late mortality risk
The FDA issued healthcare providers updated guidance for certain warning language with paclitaxel-coated devices that treat peripheral arterial disease (PAD). These PAD-treating devices produced data that does not support an excess mortality risk. Specifically, the FDA’s guidance eliminates the need for certain warning language in the device labeling. An FDA panel in 2019 determined that […]
BioCardia seeks Japanese approval of heart failure cell therapy
BioCardia (Nasdaq:BCDA) announced today that it completed the submission of its CardiAMP cell therapy system to Japan’s regulatory authorities. Sunnyvale, California-based BioCardia submitted CardiAMP to Japan’s Pharmaceutical and Medical Device Agency (PMDA). It seeks approval for the indication of ischemic heart failure with reduced ejection fraction (HFrEF). It expects a formal consultation with PMDA to […]
Telefex recall of Arrow catheter system is Class I
The FDA today designated Teleflex’s recall of its Arrow Endurance extended dwell peripheral catheter system as Class I, the most serious type of medical device recall. The recall involved 262,016 devices distributed from October 26, 2018, to May 10, 2023, according to the FDA. Teleflex and its Arrow International subsidiary have reported 83 complaints related […]
CereVasc, LianMedical announce corporate partnership
CereVasc today announced a partnership with LianMedical to bring CereVasc’s technology to Asia. The partnership aims to accelerate the introduction of breakthrough medical technologies to markets in China, Hong Kong, Taiwan and Macaw. The partnership will focus on bringing CereVasc’s eShunt system and related products to the region. “We are very excited by the opportunity […]
FDA approves Metavention’s renal denervation for hypertension pivotal IDE study
Metavention announced today that the FDA granted approval to initiate an investigational device exemption (IDE) trial for its renal denervation system. Minneapolis-based Metavention designed its integrated radiofrequency (iRF) renal denervation system to treat hypertension. The company plans for its randomized, double-blinded, sham-controlled RADAR study to enroll up to 300 patients across 50 centers. This pivotal […]
Avanos Medical to acquire Diros Technology
Avanos Medical this week announced it entered into a definitive agreement to acquire Diros Technology. Toronto-based Diros Technology develops radiofrequency (RF) products that are used to treat chronic pain conditions. Its technology delivers RF energy through precisely placed, minimally invasive probes that heat nervous tissue near the probe’s tip, deactivating the nerve’s ability to transmit […]
2-year data supports Endologix Detour system for treating PAD
About a week after garnering FDA approval, Endologix announced positive 24-month data for its Detour system for treating PAD. Irvine, California–Endologix picked up premarket approval on June 7 for its Detour system to treat long, complex superficial femoropopliteal lesions. The DETOUR2 study evaluated the system’s performance in percutaneous transmural arterial bypass (PTAB). This approach aims […]
FDA clears Pounce LP thrombectomy system from Surmodics
Surmodics (Nasdaq: SRDX) today announced that it received FDA 510(k) clearance for its Pounce low-profile (LP) thrombectomy system. News of the regulatory nod comes just one day after Needham analysts upgraded Surmodics stock from “Hold” to “Buy.” The analysts cited positive developments pointing toward the likely approval of Surmodics’ SurVeil platform sooner than previously thought. […]
FDA approves new Endologix peripheral arterial disease treatment
Endologix recently announced it received FDA approval for its Detour system to treat long, complex superficial femoropopliteal lesions. Company officials describe the Detour system as a breakthrough in the treatment of peripheral arterial disease (PAD), which the CDC estimates affected roughly 6.5 million Americans over 40. The present recommended therapy is open surgical bypass, an […]
Merit Medical spends $132.5M on acquisitions to expand its offerings
AngioDynamics (Nasdaq:ANGO) announced that it completed the sale of its dialysis product portfolio to Merit Medical Systems. It was part of a series of product acquisitions worth $132.5 million that Merit (Nasdaq: MMSI) has announced. Latham, New York-based AngioDynamics sold its dialysis portfolio and the BioSentry product for $100 million in cash. The transaction includes […]