Cardiva Medical said yesterday that it added another $11 million to a funding round it closed last year at $30 million to continue the commercialization of its Vascade vascular closure device. Existing debt and equity investors participated, including PTV Healthcare Capital, Canepa Healthcare and affiliates of Luther King Capital Mgmt., the Santa Clara, Calif.-based company said. […]
Vascular
Stryker wins expanded FDA indications for Trevo thrombectomy device
Stryker (NYSE:SYK) said today it won expanded FDA indications for its Trevo thrombectomy device, now cleared as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset. The expanded indication lifts the previously cleared treatment window by 18 hours, according to the Kalamazoo, Mich.-based company. “The 24-hour indication opens the […]
Cardiovascular Systems launches Diamondback 360 EL in the US, touts 1st patients treated
Cardiovascular Systems (NSDQ:CSII) said today it launched its FDA-cleared extended length Diamondback 360 peripheral orbital atherectomy device in the US and that the first commercial patients have been treated with the device. The first procedures were performed at the Detroit Medical Center Heart Hospital by Dr. Mahir Elder and at the Arkansas Heart Hospital by Dr. Ian […]
Veryan’s helical stent meets safety, efficacy endpoints after 12 months
Veryan‘s helical BioMimics 3D stent met its primary safety and efficacy endpoints in a study of 271 patients with symptomatic femoropopliteal artery disease, according to TCTMD. The device, which is shaped to mimic the natural geometry of human vasculature, compared favorably with drug-coated balloons and stents. The probability of maintaining primary patency after 12 months was […]
Penumbra touts non-inferiority in Compass aspiration thrombectomy trial
Penumbra (NYSE:PEN) late last month released results from the Compass trial of its aspiration thrombectomy system designed to treat acute ischemic stroke, touting that the system was shown to be non-inferior to stent retrievers. Results from the trial were presented at the International Stroke Conference, the Alameda, Calif.-based company said. Investigators in the trial aimed to […]
Surmodics misses sales estimates in Q1
Shares in Surmodics (NSDQ:SRDX) fell slightly today after the medical device maker missed expectations on Wall Street with its first quarter results. The Eden Prairie, Minn.-based company swung to a net loss of -$1.5 million on sales of $17.0 million for the 3 months ended Dec. 31, for a sales loss of -4% compared with the same […]
BTG touts one-year follow-up data for Ekos pulmonary embolism therapy
BTG (LON:BTG) touted results today from a one-year follow-up of pulmonary embolism patients who received the company’s Ekos therapy in its Optalyse PE trial. Researchers studied the 12-month outcomes of 101 patients who were treated over a shorter period and with smaller doses of thrombolytic drugs compared to the current standard. Pulmonary embolism patients treated with BTG’s Ekos […]
Teleflex wins FDA nod for next-gen peripheral snares, launches in US
Teleflex (NYSE:TFX) said today it won FDA 510(k) clearance for its Expro Elite and Sympro Elite peripheral interventional snares and that it launched the devices in the US. Both newly cleared snares are next-generation versions of 0.035″ interventional snares launched in the US in 2008 by Vascular Solutions, which is now a wholly-owned subsidiary of Teleflex. The […]
TVA Medical touts meta-analysis of everlinQ endoAVF treatments
TVA Medical today released data from a meta-analysis study of its everlinQ endovascular arteriovenous fistula system designed for hemodialysis access, touting a high procedure success rate and a high rate of fistula maturation. Results from the 236-patient trial were presented at the Leipzig Interventional Course 2018, the Austin, Texas-based company said. Data in the meta-analysis […]
Cardiovascular Systems launches Diamondback 360 in Japan, touts 1st patient treated
Cardiovascular Systems (NSDQ:CSII) said yesterday it launched its Diamondback 360 coronary OAS micro crown device in Japan, touting that the first patient had been treated with the system. The device won approval in Japan as a treatment for de novo severely calcified lesions to allow access to arteries for percutaneous coronary interventions based on data from the […]
Boston Scientific’s drug-coated balloon goes up against Medtronic’s DCB in first-of-its-kind trial
Top-line results from a head-to-head trial comparing Boston Scientific‘s (NYSE:BSX) Ranger drug-coated balloon and Medtronic‘s (NYSE:MDT) In.Pact Admiral DCB found no statistically significant difference in patency rates between the two drug-device products. The trial is the first of its kind, according to Boston Scientific’s president of peripheral interventions, Jeff Mirviss. Get the full story at our sister […]