MedAlliance this week said it received FDA breakthrough device designation for its Selution SLR sustained limus release drug-eluting balloon catheter. Selution SLR is designed to treat atherosclerotic lesions in native coronary arteries. The breakthrough designation was awarded for its design of improving luminal diameter in patients with atherosclerotic lesions. Get the full story on our […]
Vascular
ICU Medical dips despite Street-beating Q4
ICU Medical (NSDQ:ICUI) shares took a slight hit today on fourth-quarter results that topped the consensus forecast. The San Clemente, Calif.–based infusion therapy and critical care technology developer posted profits of $26.1 million, or $1.21 per share, on sales of $320.5 million for the three months ended Dec. 31, 2020, for a 2.7% bottom-line gain […]
Silk Road Medical touts results of large TCAR study
Silk Road Medical (NSDQ:SILK) touted results from a comparative effectiveness study of transcarotid artery revascularization (TCAR). Results, published in JAMA Network Open, found that the availability of TCAR at a hospital was associated with a significant decrease in the likelihood of major adverse cardiovascular events, which are a composite of in-hospital stroke, myocardial infarction or death […]
Hancock Jaffe completes $41M offering
Hancock Jaffe Laboratories (NSDQ:HJLI) announced that it successfully completed a public offering worth $41.1 million. Irvine, Calif.-based Hancock Jaffe sold more than 5.9 million shares of common stock and warrants to purchase nearly 3 million common shares in the offering, according to a news release. The $41.1 million collected in proceeds by the company are earmarked […]
Cerus Endovascular neurovascular system wins FDA breakthrough device designation
Cerus Endovascular today said it has received FDA breakthrough device designation for its Contour Neurovascular System. The Contour Neurovascular System is designed to treat intracranial aneurysms. It is made of fine mesh braid to target the neck of the aneurysm away from the vulnerable dome. It can be self-anchored for stability, is re-sheathable for precise […]
United Therapeutics launches Remunity pump for Remodulin
United Therapeutics (NSDQ:UTHR) announced today that it launched its Remunity pump for Remodulin in patients with pulmonary arterial hypertension (PAH). Research Triangle Park, N.C.-based United Therapeutics’ Remunity pump initially received FDA clearance in May 2019 for patient filling, adding another 510(k) clearance in February 2020 to enable cassettes to be prefilled with Remodulin by contracted specialty […]
Masimo completes Lidco acquisition
Masimo (NSDQ:MASI) announced that it successfully completed the previously announced acquisition of Lidco for $40.1 million. Irvine, Calif.-based Masimo acquired 100% of Lidco, a provider of advanced hemodynamic monitoring tech, on Feb. 2, 2021. Lidco was de-listed from the AIM submarket of the London Stock Exchange on Jan. 11 and will be re-registered by Masimo as […]
Medtronic wins FDA approval for DiamondTemp ablation system
Medtronic (NYSE:MDT) announced today that it received FDA approval for its DiamondTemp ablation (DTA) system for treating Afib. Fridley, Minn.-based Medtronic’s DiamondTemp ablation system treats patients with recurrent, symptomatic paroxysmal Afib who have been unresponsive to drug therapy. The medtech giant touts DiamondTemp as the first FDA-approved, temperature-controlled, irrigated radiofrequency ablation system with diamonds currently available […]
Surmodics’ DCB shown non-inferior to Medtronic’s In.Pact Admiral
Surmodics (NSDQ:SRDX) announced data showing that its SurVeil drug-coated balloon is non-inferior to Medtronic’s In.Pact Admiral. Eden Prairie, Minn.-based Surmodics’ 12-month data from the Transcend clinical trial, presented at the Leipzig Interventional Course 2021 virtual event, revealed primary results that found the SurVeil DCB is non-inferior to In.Pact Admiral in both safety and efficacy while delivering […]
Silk Road Medical issues voluntary recall of Enroute transcarotid stent system
Silk Road Medical (NSDQ:SILK) announced today that it is voluntarily recalling additional lots of its Enroute transcarotid stent system. Enroute, which is manufactured by Cardinal Health (NYSE:CAH) subsidiary Cordis, has received a total of six product complaints between September 2020 and January 2021 involving an issue in which a tip detaches from the stent delivery system. Additionally, test […]
Haemonetics to acquire Cardiva
Haemonetics (NYSE:HAE) announced today that it entered into a definitive agreement to acquire Cardiva Medical for $475 million. Boston-based Haemonetics’ agreement includes an upfront cash payment of $475 million at closing, along with up to an additional $35 million in contingent consideration based on sales growth, according to a news release. The acquisition is subject to […]
