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Latest From Trimedyne, Inc.
Directed energy device-based medical therapies have greatly influenced the way physicians deliver care in a number of medical specialties. One of the most dramatic areas of change has been in the management of benign prostatic hyperplasia, commonly referred to as an enlarged prostate. DE treatments in this area have become so popular there has been a noticeable decline in once standard surgical therapies since the late 1990s as patients have migrated to these less-invasive alternatives. This expansion in BPH DE-based therapies is being driven not only by a shift toward less-invasive treatment options, but also by the rising number of patients susceptible to prostate ailments.
Gastroesophageal reflux disease and Barrett's Esophagus seem like obvious-and enormous-potential markets for interventional devices, but so far such devices have disappointed. In GERD, product malfunctions and recalls have underscored safety issues, while efficacy concerns and reimbursement delays have conspired to keep the enormous opportunity that GERD represents tantalizingly out of reach for many of the first-generation companies that were launched to tap into this market. Now, a small group of companies with hopes of a better approach are betting they've found the way to harness this most promising of device markets.
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.
Ten years ago, researchers observed that injecting vascular endothelial growth factors or fibroblast frowth factors into animal models of ischemia stimulated the formation of new blood vessels. The discovery that, with a bit of prompting, the body's natural capacity for angiogenesis could be accelerated, has drawn more than a dozen drug firms and a handful of cardiovascular device companies into the search for a biological alternative that can aid or replace current cardiovascular interventions, or even delay the progression of heart disease.
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- Mobile Surgical Technologies, Inc.