Spectranetics (NSDQ:SPNC) today released 12-month data from the Illumenate global study of its Stellarex drug-coated balloon in treating peripheral artery disease in superficial femoral and popliteal arteries, touting a high rate of primary patency in patients with complex lesions. The 371-patient Illumenate global study included lesions which were “highly complex,” according to the Colorado Springs, Colo.-based company, and […]
Spectranetics Corp.
Spectranetics wins CE Mark for smaller Stellarex DCB
Spectranetics (NSDQ:SPNC) said yesterday that it won CE Mark approval in the European Union for a smaller size of its Stellarex drug-coated balloon. The Stellarex 0.014” device is designed to treat small vessels, below-the-knee disease and challenging critical limb ischemia. The larger, 0.035” device won CE Mark approval in December 2014, just before Spectranetics paid Covidien $30 million deal […]
Spectranetics releases final 1-year results for Stellarex drug-coated balloon
Spectranetics (NSDQ:SPNC) today released the final 1-year results from the Illumenate EU RCT study comparing treatment with its Stellarex drug-coated balloon to percutaneous transluminal angioplasty, touting a 24% higher rate of primary patency with the DCB. One-year results from the 328-patient trial were presented at the Amputation Prevention Symposium in Chicago this week. “The Stellarex […]
Spectranetics wins CE Mark for AngioSculptX drug-coated ‘scoring’ balloon
Spectranetics (NSDQ:SPNC) said today it won CE Mark approval in the European Union for its AngioSculptX drug-coated PTCA scoring balloon catheter designed to treat coronary artery stenosis. The device won indications for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restinosis, the Colorado Springs, Colo.-based company said. “AngiosculptX represents a unique coronary scoring […]
Appeals court tosses $20m AngioScore win over TriReme Medical
A federal appeals court yesterday tossed AngioScore‘s $20 million win over TriReme Medical and a pair of related companies, ruling that the case never should have made it to the federal level. Just more than a year ago, Judge Yvonne Gonzalez Rogers of the U.S. District Court for Northern California ruled that AngioScore founder Eitan Konstantino violated his duties to AngioScore when […]
FDA warns Spectranetics on Glidelight, SLS II lead extraction sheaths
The FDA sent a warning letter last month to Spectranetics (NSDQ:SPNC), flagging the company for problems with its GlideLight and SLS II lead extraction sheaths made in Colorado. The FDA inspected Spectranetics’ Colorado Springs facility from the end of November 2015 through January 21, issuing a Form 483 warning based on problems found during the inspection. […]
The exodus of key personnel at Google’s Verily | Personnel Moves for March 29, 2016
There’s reportedly a rare exodus under way of key personnel from a Google (NSDQ:GOOG) operation, its Verily healthcare “moonshot,” with former employees blaming the mercurial leadership of CEO Andrew Conrad. A dozen top engineers, scientists and managers have departed since Verily, formerly Google Life Sciences, was launched 3 years ago, according to the Stat website. […]
Spectranetics wins FDA nod for Bridge occlusion balloon
Spectranetics (NSDQ:SPNC) said today it won FDA 510(k) clearance for its Bridge occlusion balloon designed to temporarily occlude vessels during cardiac lead extraction procedures. The Colorado Springs, Colo.-based company’s Bridge balloon is designed to reduce blood loss in the event of a tear and to provide a “bridge” to surgical intervention. “The Bridge occlusion balloon […]
Appeals court reverses TriReme patent loss to AngioScore
CORRECTED July 22, 2016. This article originally transposed the patent infringement lawsuit filed by TriReme against AngioScore for a breach-of-contract lawsuit filed by AngioScore. A federal appeals court today reversed a lower court’s patent infringement ruling that went against TriReme Medical and a pair of related companies in favor of AngioScore, sending the case back to a lower court […]
Spectranetics wins 510(k) clearance for laser atherectomy cath
Spectranetics (NSDQ:SPNC) said yesterday it won FDA 510(k) clearance for its next-generation Turbo-Power laser atherectomy catheter for treating in-stent restenosis. The Turbo-Power laser catheter treats at the tip and debulks lesions in a single step with remote automatic rotation for accurate directional control, the Colorado Springs, Colo.-based company said. “Patients with ISR present the most […]
VIVA 2015 Roundup: Medtronic touts Valiant stent graft, PAD stent-treatment data
Medtronic (NYSE:MDT) this week presented data from 2 studies of its stent systems and announced a new study of its In.Pact Admiral drug-coated balloon. The announcements were made at the VIVA physicians annual conference in Las Vegas, Nev. The Fridley, Minn.-based medical giant presented data from a 2-year clinical trial of its Valiant Captivia thoracic stent graft […]