It will provide additional update on this issue during its upcoming first-quarter fiscal 2023 earnings call. The company is currently evaluating the issues raised in the letter and will meet the agency’s representatives for discussing the letter’s content and conclude the path forward for the PMA application.
Surmodics will now perform the required testing and analysis for submitting the requested data. However, the letter from the FDA did not raise any question on the human clinical data from the TRANSCEND study. The new information requested by the FDA to put the PMA application in approvable form will require additional testing and analysis. The FDA suggested adding certain information within two general categories - biocompatibility and labeling - through an amendment to the company’s PMA application. The letter received by Surmodics from the FDA related to SurVeil DCB PMA application stated that it is currently unapprovable, and also provided specific guidance for path forward. Image Source: Zacks Investment Research The FDA Letter Per Medtronics website, IN.PACT Admiral DCB is the market-leading DCB that has demonstrated durable, consistent, and safe outcomes across multiple clinical trials. A 24-month data from the TRANSCEND study demonstrated continuous improvement in functional outcomes for treated patients, which was comparable to Medtronic’s IN.PACT Admiral DCB. SurVeil DCB also delivered a substantially lower drug dose versus MDT’s IN.PACT Admiral DCB.
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Data from the TRANSCEND 12-month pivotal clinical trial showed that SurVeil DCB met both the primary safety and primary efficacy endpoints that were found to be non-inferior compared to Medtronic’s IN.PACT Admiral DCB. TRANSCEND Study Dataĭata from the TRANSCEND study demonstrated compelling performance for SurVeil DCB.
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The study compared the results with Medtronic’s ( MDT Quick Quote MDT - Free Report) IN.PACT Admiral DCB, which was evaluated in the comparator-arm, for non-inferiority. The study evaluated the safety and efficacy of SurVeil DCB, a next-generation device for the treatment of peripheral artery disease (PAD). The company completed the submission of the PMA application for SurVeil DCB in the third quarter of 2021, based on data from clinical trial - TRANSCEND. Surmodics announced last week that it has received a letter from the FDA indicating that a premarket approval (“PMA”) application for its SurVeil DCB is not currently approvable. The S&P 500 Index has declined 0.4% in the same time period. In fact, the company’s shares have declined 33.3% in the past six months against the industry’s 0.9% increase. ( SRDX Quick Quote SRDX - Free Report) have declined 31.8% since the close on Jan 18, following disappointing regulatory update related to its SurVeil drug-coated balloon (“DCB”). Options include a SOMOS ® RDX clean room variant and mobile trolley mounting of the small-volume dryer.Shares of Surmodics, Inc. In the case of automatic dryer filling, sliding sensors on the drying hopper enable flexible filling level adjustment. The dryers respond automatically to changing throughputs and adjust the drying temperature to current material consumption, reducing the temperature if production is interrupted. Thanks to the modular, "switch-over" design of the dryers, a single air compressor can supply a number of drying bins in parallel, which can be interconnected with further dryers in a remote mode. The air is then heated to the required drying temperature and distributed uniformly in the drying bin by means of a ring nozzle system. The drying process efficiently makes use of predried air from the in-plant compressed air system, dry process air with a very low dew point being obtained by expanding the compressed air to atmospheric pressure.
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The attachment dryers are simple to install on processing machinery. adsorption dryers): the compressed air technology used combines perfect drying results with minimal operating costs and virtually maintenance free operation. They are ProTec's way of providing an economic alternative to conventional drying systems (e.g. SOMOS ® RDX attachment dryers are designed for drying small volumes of polymer pellets with throughputs of around 8 to 10 kg/h using in-plant compressed air.
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