Medtronic (NYSE:MDT) today announced that it enrolled the first patient in a head-to-head trial of aortic stent graft systems. The Advance trial evaluates the Medtronic Endurant II/IIs and the Gore Excluder AAA device family. Medtronic said in a news release that it expects to enroll 550 patients at up to 50 global centers in the […]
Stents
The top 10 cardiac device stories of 2022
From pulsed-field ablation to noninvasive monitoring, this was an exciting year for cardiac device tech. Here are the top 10 cardiac device stories from MassDevice and its sister sites: 10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio Earlier this year, Acutus agreed to sell its left-heart access portfolio to […]
Silk Road Medical ticks up on Street-beating Q3 results
Silk Road Medical (NSDQ:SILK) this week posted third-quarter results that beat the overall consensus on Wall Street. The Sunnyvale, California-based stroke treatment tech company reported net losses of $10.3 million, or -29¢ per share, on sales of $37.4 million for the three months ended Sept. 30, on sales growth of 51.31% and profit gain from […]
InspireMD grows sales 33% in Q3
InspireMD (NYSE:NSPR) this week posted third-quarter results that beat the overall consensus on Wall Street. The Tel Aviv, Israel-based company reported net losses of $4.5 million, or -58¢ per share, on sales of $1.43 million for the three months ended Sept. 30, for a sales growth of 33.61% compared with Q3 2021. Earnings per share […]
Surmodics enters credit agreement worth up to $125M
Surmodics (Nasdaq:SRDX) announced today that it entered into a new five-year credit agreement with MidCap Financial worth $125 million. Eden Prairie, Minnesota-based Surmodics’ agreement includes up to $100 million in term loans and a $25 million revolving credit facility. Surmodics has pioneered lubricious, hemocompatible, and drug-delivery coatings for major medical device companies. “We are pleased […]
FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions. Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions (PCIs). It applies to the FDA-approved and CE-marked Onyx […]
Getinge partners with Medtronic to make Radiant balloon-expandable covered stent
Getinge today announced a partnership with Medtronic (NYSE:MDT) over the Radiant balloon-expandable stent, which received CE mark. Radiant is designed for use in chimney endovascular aneurysm repair (ChEVAR) with the Endurant II/IIs stent graft system. It maintains perfusion to renal arteries when used in combination with the stent graft. The medtech giant said that Radiant is […]
Supira Medical announces first in-human use of pVAD
Supira Medical announced today that it initiated the first-in-human clinical study of its percutaneous ventricular assist device (pVAD). Los Gatos, California-based Supira, a Shifamed portfolio company, is using the pVAD in a prospective, single-arm, single-center study. It will evaluate the safety and performance of the low-profile, high-flow pVAD. Can Supira’s pVAD support cardiovascular hemodynamics in […]
FDA clears Rapid Medical’s small, adjustable thrombectomy device
Rapid Medical announced that it received FDA 510(k) clearance for its Tigertriever 13 device for treating large vessel occlusions. Yokneam, Israel-based Rapid Medical designed Tigertriever 13 to remove thrombus from delicate brain blood vessels during an ischemic stroke. Rapid Medical said in a news release that Tigertriever 13 is the smallest revascularization device in the […]
FDA approves Biotronik’s self-expanding stent system
Biotronik announced today that it received FDA approval for its Pulsar-18 T3 peripheral self-expanding stent system. Pulsar-18 T3 combines a 4-French low-profile delivery system with a tri-axial system with a braided shaft design and thin struts with low chronic outward force (COF), creating an improved implantation procedure for endovascular treatments. According to a news release, […]
Cordis begins enrollment in study of lesion treatment
Cordis announced that it began the Radiancy pre-market clinical study of its vascular stent system for treating lesions. Miami Lakes, Florida-based Cordis’ prospective, multi-center, single-arm study in Europe will assess the safety and efficacy of the SMART Radianz vascular stent system for the treatment of lesions in the iliac, superficial femoral or proximal popliteal arteries […]