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Transcatheter Cardiovascular Therapeutics industry round-up November 2006

FDA happenings: FDA to review late thrombosis in drug-eluting stents; Agency grants HUD exemption to implantable artificial heart; Agency approves integrated IVUS-imaging technology Around the industry: J&J sues BSC, Abbott over Guidant acquisition; HUD exemptions for PFO devices withdrawn; FoxHollow acquires Kerberos; and more Proceedings of TCT 3, 15-16 (2006). view PDF

CMS considers expanding carotid stenting coverage

The Centers for Medicare and Medicaid Services (CMS) are considering an expansion of coverage for carotid angioplasty and stenting (CAS) with embolic protection to include, among other groups, patients at high risk for the surgical alternative (carotid endarterectomy, CEA) who have asymptomatic carotid stenosis of at least 80%. A key consideration that will drive thisContinueContinue reading “CMS considers expanding carotid stenting coverage”

Hybrid cell technologies show promise in treating ischemia

By combining cell therapy techniques with tissue engineering—two approaches that have produced mixed results on their own—researchers are attempting to effect myocardial repair after a heart attack, as well as interrupt the cellular cascade that leads from myocardial infarction (MI) to eventual heart failure. Each approach has its strengths and drawbacks, researchers reported at theContinueContinue reading “Hybrid cell technologies show promise in treating ischemia”

Benefit of embolic protection differs in different settings

The potential clinical benefit of embolic protection during percutaneous intervention is not a yes-or-no question but varies with the type of device used and the anatomic system involved. Initially developed and tested in saphenous vein grafts, embolic protection devices have now been applied in coronary (myocardial infarction), carotid, and renal settings. Results have been disapppointingContinueContinue reading “Benefit of embolic protection differs in different settings”

Transcatheter Cardiovascular Therapeutics industry round-up June 2006

FDA happenings: Agency to increase oversight of heart devices; Agency approves Micro-Driver stent; Introducer sheath gains clearance; and more Around the industry: Safety advisories issued for Guidant products; CMS reimbursement changes threaten device industry; India to regulate implantable devices; and more Proceedings of TCT 3, 10-12 (2006). view PDF

PFO closure for migraines remains an open question

Though greatly anticipated, results of the MIST (Migraine Intervention with STARFlex Technology) trial, presented during the Innovation in Intervention Summit at the annual meeting of the American College of Cardiology in March 2006, failed to prove the benefits of patent foramen ovale (PFO) closure in migraine prevention. The MIST results add to the body ofContinueContinue reading “PFO closure for migraines remains an open question”

Transcatheter Cardiovascular Therapeutics industry round-up April 2006

FDA happenings: More QC troubles at Guidant; Label expansion for Medtronic CRTs; FDA announces Critical Path opportunities list; and more Around the industry: Boston Scientific-Guidant merger cleared by FTC; Guidant suspends use of Xience V; Conor licenses pimecrolimus from Novartis; and more Proceedings of TCT 3, 21-24 (2006). view PDF

Nonautologous cells progress toward clinical trials

Although nonautologous cells are increasingly considered the best cell-based method for treating cardiovascular disease, their therapeutic application has thus far been hindered by a lack of knowledge concerning their immunogenicity, ideal conditions for differentiation, and mechanisms for introducing them into damaged hearts. Presentations at the Second International Conference on Cell Therapy for Cardiovascular Disease inContinueContinue reading “Nonautologous cells progress toward clinical trials”

State of the art of CTO revascularization

Since the First International Chronic Total Occlusion Summit in 2004, advances in tools and techniques and in patient selection and safety have improved the potential for successful chronic total occlusion (CTO) treatment. This progress is reflected in the live case success rates for the three CTO Summits. Proceedings of TCT 3, 12-14 (2006). view PDF

DES data in high-risk subgroups presented

In addition to addressing the safety and efficacy of drug-eluting stents (DES) in general and relative to one another, randomized controlled trials and registries are now beginning to assess specific lesion subgroups for which DES are not currently approved in the US. These include in-stent restenosis, saphenous vein grafts, bifurcation lesions, left main disease, andContinueContinue reading “DES data in high-risk subgroups presented”