RenovoRx said today that it closed a $7 million tranche in a $10 million round to fund the development of its drug-device combination product designed to deliver chemotherapy directly to tumors in patients with locally advanced pancreatic cancer. The company’s round was led by Boston Scientific (NYSE:BSX) and joined by btov Partners, Astia Angels, Golden Seeds and others. […]
Vascular
Inari Medical wins FDA 510(k) for FlowTriever
Inari Medical said today it won FDA 510(k) clearance for its FlowTriever stent retriever designed to treat pulmonary embolisms. The clearance came based upon results from the company’s Flare clinical study of the device, which examined data from 106 patients with acute pulmonary embolisms treated with the FlowTriever at 18 US sites, the Irvine, Calif.-based company […]
J&J’s Cerenovus wins FDA nod for Embotrap II revascularization device
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today it won FDA 510(k) clearance for the Embotrap II revascularization device. The Irvine, Calif.-based J&J division said that the device is designed to quickly restore natural blood flow by retrieving emboli within the vasculature of the brain, using minimal compression to protect against further complications. Approval of the device came […]
Medtronic recalls select MindFrame Capture revascularization devices
The FDA today released a recall notice for a select number of Medtronic (NYSE:MDT) MindFrame Capture LP revascularization devices over issues with the delivery wire breaking or separating during use. The federal watchdog labeled the recall as a Class I, its most serious class of recall, which indicates the potential for serious injury or death. […]
InspireMD wins regulatory nod in Ecuador for CGuard, MGuard
InspireMD (NYSE:NSPR) said this week it won regulatory approval in Ecuador for its CGuard embolic prevention system and MGuard Prime devices. The approval comes shortly after the company inked an exclusive distribution agreement with Ecuadorian medical device distributor Cardiobene, Israel-based InspireMD said. Both companies have worked together to secure regulatory approvals in the country, InspireMD added. “We […]
NeuroVasc Tech raises $6m in Series B
NeuroVasc Technologies said yesterday it closed a $6.3 million Series B preferred stock round. The round was joined by multiple investors, and led by ShangBay Capital, the Laguna Hills, Calif.-based company said. NeuroVasc Tech is developing treatments for neurovascular conditions with a focus on treating ischemic stroke, and currently has CE Mark approval in the […]
Teleflex launches TrapLiner cath in the EU
Teleflex (NYSE:TFX) said yesterday it launched the TrapLiner catheter, designed for use in vascular procedures, in Europe. The Wayne, Penn.-based company said that its TrapLiner cath is similar in design to its GuideLiner V3 cath but also features an integrated balloon for trapping standard 0.014″ guidewires within a guide catheter. The newly launched TrapLiner catheter is […]
Medtronic launches study of drug-eluting stent as treatment for bifurcation lesions
Medtronic (NYSE:MDT) today launched a study to evaluate the safety and efficacy of its Resolute Onyx drug-eluting stent for the treatment of bifurcation lesions in patients with coronary artery disease. The medtech giant said that bifurcation lesions make up nearly 20% of all percutaneous coronary interventions. The assessment of DES tech in this patient group is part […]
Reva touts first implant of bioresorbable scaffold in Turkey
Reva Medical (ASX:RVA) said today that the company launched its Fantom bioresorbable scaffold in Turkey. There are nearly 100 hospitals performing cardiac catheterizations in Istanbul, according to Reva. The San Diego, Calif.-based company highlighted Turkey as an important market for bioresorbable technologies, noting that it has a commercial distribution deal in the country with Kardionet Healthcare and Foreign […]
Boston Scientific’s drug-coated balloon succeeds in femoropopliteal segment at one year
Data from Boston Scientific‘s (NYSE:BSX) Ranger SFA trial showed that treatment with its drug-coated balloon succeeded in the femoropopliteal segment after one year and resulted in greater rates of patency, with fewer interventions, compared to standard balloon angioplasty. The results, which were published this month in JACC: Cardiovascular Interventions, demonstrated that both groups of patients – those […]
FDA warns on stents associated with stent-assisted neurovascular coiling procedures
The FDA today warned about risks associated with the use of neurovascular stents used in stent-assisted coiling procedures after receiving a number of reports that suggest possible associations between peri-procedural stroke or death with the use of the devices. The federal watchdog warned of procedural risks or patient selection related health factors associated with the […]