Veniti said today that Boston Scientific (NYSE:BSX) put up $25 million for its Series D round, which it plans to use to back a clinical trial of its Vici venous stent. Veniti’s 200-patient, 60-month Virtus trial, run under an investigational device exemption from the FDA, is a single-arm safety & efficacy study with a main safety endpoint of major adverse […]
Peripheral
Avinger prices $30m follow-on offering
Avinger (NSDQ:AVGR) today priced a follow-on offering worth $30 million, saying it plans to dip into the cash if it needs to cover penalties for missed revenue covenants this year. Redwood City, Calif.-based Avinger said it plans to float nearly 8.6 million shares at $3.50 apiece, plus a possible 1.3-million-share underwriters over-allotment that could bring in another […]
Avinger lowers outlook on Q2 sales prelims
Avinger (NSDQ:AVGR) shares are off nearly 39% today after the company released lower-than-expected preliminary 2nd-quarter sales numbers and lowered its outlook for the rest of the year. Redwood City, Calif.-based Avinger, which makes the Pantheris image-guided atherectomy device for treating peripheral artery disease, said it expects to post sales of $4.7 million for the 3 months ended June […]
FDA approves longer version of Medtronic’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that the FDA approved a longer version of its In.Pact Admiral drug-coated balloon for treating peripheral artery disease. The 150mm-lenth device is available in 4mm, 5mm and 6mm diameters, the Fridley, Minn.-based company said. The FDA originally cleared the In.Pact Admiral DCB in January 2015, about 6 years after it won […]
Shareholder sues as Cardiovascular Systems wins extension to settle kickbacks case
A Cardiovascular Systems (NSDQ:CSII) shareholder sued the company in a derivative lawsuit this week, even as the medical device maker won an extension to negotiate a settlement in the very kickbacks case that prompted the derivative claim. In the shareholder derivative suit filed yesterday, plaintiff Caroline Paradis alleged that Cardiovascular Systems and its management – including the late David Martin, the former […]
Advanced Catheter Therapies inks deal with Toray Industries for peripheral catheter
Advanced Catheter Therapies said today that it inked a worldwide license deal with Toray Industries for the manufacture and sale of ACT’s Occlusion Perfusion Catheter for peripheral vascular stenosis and restenosis. Chattanooga, Tenn.-based ACT said it’s been manufacturing the OPC device for about a year for clinical trials and a test release. “Our 1st-in-human clinical trials have been very […]
Eximo Medical’s hybrid catheter clears pivotal trial
Eximo Medical said a 20-patient pivotal trial in Europe, aimed at winning CE Mark approval there for its hybrid peripheral catheter, met its safety and efficacy endpoints. Rehovot, Israel-based Eximo’s device is designed to combine laser ablation with a blunt, bladed tip to clear partial or full peripheral blockages. The company said it’s pursuing the CE […]
SurModics launches 1st-in-human trial for SurVeil drug-coated balloon
SurModics (NSDQ:SRDX) said it enrolled the 1st patient in an early feasibility trial of its SurVeil drug-coated balloon for treating peripheral artery disease, as it looks to metamorphose from device coating provider to medical device maker. The FDA granted investigational device exemption for the trial late last year, the Eden Prairie, Minn.-based company said. The […]
Penumbra launches Lantern peripheral microcatheter
Penumbra said it launched its Lantern peripheral microcatheter and reported Phase IV data from a 100-patient trial of its Indigo peripheral thrombectomy device. The Lantern device won 510(k) clearance from the FDA in December 2015 for the peripheral and neurovascular delivery of diagnostic agents and therapeutic devices such as occlusion coils. Alameda, Calif.-based Penumbra makes the Ruby […]
FDA clears Corindus Vascular Robotics CorPath for peripheral interventions
Corindus Vascular Robotics (NYSE:CVRS) said today that it won FDA 510(k) clearance for its robotic-assisted CorPath system for peripheral interventions, a year after launching a clinical trial. The clearance was based on the 20-patient Rapid trial, a prospective, single-arm, single-center study designed to look at the safety and effectiveness of the CorPath device in peripheral artery disease patients with lower-extremity […]
Trial kicks off in 10-year-old Abbott stent case
A 10-year-old whistleblower lawsuit filed by a former Abbott (NYSE:ABT) sales rep, over the alleged off-label marketing of biliary stents, finally went to trial in Dallas yesterday. Plaintiff Kevin Colquitt, a former rep for Abbott’s Guidant division, sued Abbott, Johnson & Johnson (NYSE:JNJ) and Boston Scientific (NYSE:BSX) in 2006, claiming that they marketed the use of biliary stents to treat peripheral artery disease. (The magistrate overseeing […]