Surmodics (Nasdaq:SRDX) today announced positive study results for two of its drug-coated balloon (DCB) technologies. The company presented data supporting the SurVeil and Sundance DCBs at the 50th Annual VEITH Symposium in New York. In the TRANSCEND trial, Surmodics evaluated the safety and efficacy of SurVeil versus the Medtronic In.Pact … [Read more...] about Surmodics has positive data on multiple drug-coated balloons
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Surmodics launches new medical device coating technology
Surmodics (Nasdaq:SRDX) announced today that it launched its most advanced hydrophilic medical device coating technology. Eden Prairie, Minnesota-based Surmodics designed the Preside coatings to complement its existing Serene hydrophilic coatings. Preside offers a unique, low-friction and low-particulate generation coating. It further enhances … [Read more...] about Surmodics launches new medical device coating technology
Surmodics more than doubles sales in Q3
Surmodics (Nasdaq:SRDX) this week announced third-quarter results that beat the overall consensus on Wall Street. The Eden Prairie, Minnesota-based company reported profits of $7.3 million, or 52¢ per share, on sales of $52.5 million for the three months ended June 30. Compared to Q3 2022, the company had a sales gain of 111.2% and profit gains … [Read more...] about Surmodics more than doubles sales in Q3
Cook Medical has more hydrophilic PTA balloon catheter options
Cook Medical today announced more sizes and locations for the Advance Serenity hydrophilic PTA balloon catheter product line. It's now possible for U.S. and Canadian interventionalists to use Advance Serenity for below-the-knee and above-the-knee procedures to treat patients with peripheral artery disease (PAD), according to Cook Medical. In … [Read more...] about Cook Medical has more hydrophilic PTA balloon catheter options
FDA approves Surmodics SurVeil drug-coated balloon
Surmodics (Nasdaq:SRDX) announced today that the FDA granted approval for its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota–based Surmodics may now market and sell SurVeil in the U.S. for percutaneous transluminal angioplasty. Use follows appropriate vessel preparation or de novo or restenotic lesions in femoral and popliteal … [Read more...] about FDA approves Surmodics SurVeil drug-coated balloon
FDA clears Pounce LP thrombectomy system from Surmodics
Surmodics (Nasdaq:SRDX) today announced that it received FDA 510(k) clearance for its Pounce low-profile (LP) thrombectomy system. News of the regulatory nod comes just one day after Needham analysts upgraded Surmodics stock from "Hold" to "Buy." The analysts cited positive developments pointing toward the likely approval of Surmodics' SurVeil … [Read more...] about FDA clears Pounce LP thrombectomy system from Surmodics
Surmodics enrolls first patient in Pounce thrombectomy system registry study
Surmodics recently announced it enrolled the first patient in its Prowl registry study of its Pounce thrombectomy system. Prowl is an open-label, retrospective, multi-center, U.S. registry of the Surmodics Pounce system for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. The registry aims to collect … [Read more...] about Surmodics enrolls first patient in Pounce thrombectomy system registry study
Surmodics grows sales 4% in Q2
Surmodics (Nasdaq:SRDX) this week posted second-quarter results that missed the earnings consensus on Wall Street but beat sales estimates. The Eden Prairie, Minnesota-based company reported profit losses of $7.7 million, or 55¢ per share, on sales of $27.2 million, for the three months ended March 31, for a bottom-line loss compared to Q2 2022, … [Read more...] about Surmodics grows sales 4% in Q2
Surmodics touts first successful patient use of Sublime radial access microcatheter
Surmodics this week announced it successfully used its Sublime radial access microcatheter in a patient for the first time. The company designed the device to enable peripheral access for the delivery of diagnostic and therapeutic agents, such as drugs and stents, to treat various medical conditions. Sublime is in limited market evaluation … [Read more...] about Surmodics touts first successful patient use of Sublime radial access microcatheter
Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is … [Read more...] about Surmodics targets FDA premarket approval for drug-coated balloon in Q4