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
surmodics
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
Surmodics is laying off roughly 60 workers
Surmodics (Nasdaq: SRDX) announced a restructuring that includes cutting 13% of the workforce at the Eden Prairie, Minnesota-based IVD tech developer. In its most recent annual report, Surmodics listed a headcount of 447, which means the layoff could involve nearly 60 workers. The cost-reduction plan will save roughly $10 million to $11 million … [Read more...] about Surmodics is laying off roughly 60 workers
Surmodics announces regulatory delay for its SurVeil balloon
The FDA said it needed more information on biocompatibility and labeling.
The FDA has indicated that Surmodics' Surveil drug-coated balloon premarket approval application is not approvable.
According to an FDA letter to the company, Surmodics' Surveil was not approved due to certain information in the biocompatibility and labeling categories. The governing agency said more information needs to be added by an amendment … [Read more...] about Surmodics announces regulatory delay for its SurVeil balloon
Surmodics beats The Street in Q4 results, grows sales 8%
Surmodics (Nasdaq:SRDX) today posted fourth-quarter results that beat the overall consensus on Wall Street. The Eden Prairie, Minnesota-based IVD tech developer reported net losses of $14.7 million, or -$1.06 per share, on sales of $25.99 million for the three months ended Sept. 30, representing a sales growth of 8.41% compared to Q4 2021. The … [Read more...] about Surmodics beats The Street in Q4 results, grows sales 8%
