
Leerink Swann analysts saw promise in a pair of "tidbits" about Edwards Lifesciences’ (NYSE:EW) Sapien XT transcatheter aortic valve implantation system presented at the EuroPCR conference in Paris this week.
News of positive 30-day outcomes from the large "real life" European Source XT post-approval registry and CE Mark approval in the European Union for a larger Sapien XT valve size were "small incremental positives" for the Irvine, Calif.-based device maker.
Although unlikely to create a major reaction on Wall Street, the reports are "encouraging," according to the analysts.
Results from the post-approval registry for the Sapient XT, the 2nd generation of the company’s valve, found overall positive outcomes for the more than 2,700 patients at 30 days with low all-cause mortality and low procedure-related complications.
Edwards also won CE Mark approval for a larger 29 mm Sapien XT valve, allowing the device to cover a broader range of patient anatomies. It also allows Sapien XT to compete more directly with Medtronic’s (NYSE:MDT) CoreValve, the analysts wrote.
EW shares were down 0.3% to $82.84 as of about 2:15 p.m. today.
FFR may reduce revascularization risk in some patients
Newly released results from the Fame II study highlighted the importance of picking the right patients to undergo percutaneous coronary intervention. Researchers showed that targeting patients with ischemia for treatment with fractional flow reserve guided PCI and optimal medical treatment may reduce the need for revascularization.
Read more
Researchers plan the largest drug-eluting stent trial to date
Investigators announced plans for the "largest ever clinical trial involving a drug-eluting stent," planning to enroll around 16,000 patients from an "all-comers" population to receive either BioMatrix’s Flex DES or drug therapy.
Read more
Semi-bioabsorbable stent may reduce risk of adverse events
New study results show that implanting semi-bioabsorbable biolimus-eluting stents in patients with ST-elevation MI may greatly reduce the risk of major adverse cardiac events when compared with bare-metal stents.
Read more
TAVI increasingly popular in Europe
As hospitals acquire expertise and reimbursement policies catch on, the number of transcatheter aortic valve implantation procedures has more than tripled in the last 3 years.
Read more
OrbusNeich’s stent promotes healing faster than BSX’s Taxus
OrbusNeich touted its Combo Dual Therapy stent, finding an early advantage in vascular healing when compared with Boston Scientific’s (NYSE:BSX) Taxus drug-eluting stent.
Read more
InspireMD touts 3-year results from Magical trial of its MGuard
InspireMD (OTC:NSPR) revealed 3-year results from the Magical trial of its MGuard stent platform in patients with acute myocardial infarction, showing safety and efficacy with a 10.5% rate of major adverse cardiac events and no reduction in cardiac function.
Read more
Medtronic’s CoreValve TAVI system results are gender-neutral
Medtronic (NYSE:MDT) touted study results from a secondary endpoint of its Advance trial, finding that patient outcomes for treatment with the CoreValve TAVI system were similar between men and women.
Read more
Stentys self-apposing stent shows very low early mortality
Stentys SA (EPA:STNT) unveiled study results finding very low early mortality rates for its Stentys self-apposing stent system in treating acute myocardial infarction. The 30-day mortality rate was 1.2% and the major adverse cardiovascular events rate was 3.5%.
Read more