Putting Things in Place in TMR
Development in transmyocardial revascularization suggest this promising technology may be getting ready for a major run.
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DIRECT, the first placebo-controlled trial of a laser myocardial revascularization technology, did not prove any benefit from the therapy, an announcement that has stirred a hornet's nest of controversy in the TMR/PMR industry. Laser companies and physicians who perform the procedures have been in damage control mode since the announcement. The event has exacerbated the challenges that laser companies were already facing in the early adoption phase of a new treatment paradigm. PLC Systems and Eclipse Surgical feel confident that their technologies are sufficiently different from that used in the DIRECT trial and are striving to reassure physicians, patients and investors. In its efforts to convince skeptical physicians or those put off by the DIRECT results, PLC is banking on its perfusion data and its positive 5-year results for its surgical TMR approach. Eclipse hopes positive results from its clinical trial will help it get approval for the first interventional approach.
Pembrolizumab should be considered the new standard of care as first-line therapy in patients with microsatellite instability high (MSI-H) metastatic colorectal cancer, KEYNOTE-177 investigator André said.
Amivas requested a US tropical disease PRV for intravenous artesunate but FDA has not yet made a decision on eligibility; approval appears to block La Jolla’s competing product, currently under review, for seven years.