Boston Scientific, Elixir make waves at EuroPCR 2013

A who's who of medical device outfits have taken to Paris this week for EuroPCR, flaunting their latest data and devices to a gathering of the continent's interventional cardiovascular specialists. Below is a look at the highlights from Day Two. Check out our Day One coverage here.

The Promus Premier, right, and Synergy stents--Courtesy of Boston Scientific
Boston Scientific ($BSX) is touting excellent results for its next-generation stents, hailing the Promus Premier and Synergy implants as major steps forward for the company's cardiovascular business. First, Promus Premier: The new stent aced its first human trial, reporting a technical success rate of 99.2% with 0% rates of target lesion revascularization and stent thrombosis. The everolimus-eluting stent has a low-profile delivery system and customizable architecture, allowing it to treat challenging coronary lesions, the company said. Synergy, Boston Scientific's first foray into the dissolvable stent world, has so far proven just as effective as the company's long-running Promus Element, notching rates of 1.1% target lesion revascularization and 0% stent thrombosis after two years. That 1.1% revascularization figure is well below Promus Element's 6.1% rate, Boston Scientific notes, suggesting that the absorbable device could provide long-term benefits over traditional polymer-coated stents. Both devices are CE marked but are yet to be approved by the FDA. Studies
 
Courtesy of Elixir Medical
Elixir Medical unveiled the results of a pivotal trial for its DESolve drug-eluting stent, reporting that in a study of 126 patients, the dissolving device successfully propped open vessels and notched just a 3.25% rate of major adverse cardiac events. The device won a CE mark earlier this month, and Elixir is competing with Abbott Laboratories' ($ABT) Absorb device, which has been on the market overseas since September. Elixir believes its device, which dissolves faster than Abbott's, has a chance to carve out a share of the market. Neither device has received FDA approval, but Abbott is in the midst of a large-scale U.S. study with eyes on the U.S. More from FierceDrugDelivery
 
Courtesy of Medtronic
Medtronic ($MDT) revealed more positive results for its banner Resolute Integrity stent treating coronary bifurcation lesions, buildups of plaque around the junction of two coronary arteries. Looking at a registry of about 3,500 Resolute Integrity implantations, Medtronic found no statistical differences between patients with and without bifurcation lesions after three years. In a separate study of 527 patients in Italy, the stent notched a low target lesion revascularization rate of 5.1% after two years. In a third study, Resolute Integrity beat out Boston Scientific's Promus Element and Abbott's Xience Prime in maintaining position within the artery. Medtronic credits the strong performance in bifurcation lesions to Resolute Integrity's conformability, allowing it to treat complicated anatomies. In the U.S., the stent is FDA approved but not yet indicated for bifurcation lesions. Results
 
Courtesy of St. Jude Medical
St. Jude Medical ($STJ) is blazing a trail with its EnligHTNment study, testing whether the company's renal denervation device can benefit patients beyond lowering hypertension, improving rates of heart attack, stroke, heart failure and cardiovascular death. St. Jude announced the study's launch at EuroPCR, planning to use its EnligHTN device on about 4,000 patients with uncontrolled hypertension around the world with a primary endpoint of reducing major cardiovascular events. If successful, St. Jude's study could significantly broaden indications for renal denervation devices, already predicted to be worth about $3 billion within the decade. Neither St. Jude nor its competitors has won FDA approval for renal denervation, but Medtronic expects to be the first, targeting a 2015 launch for its Symplicity system. More
 

Check back for more EuroPCR coverage throughout the week.

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