Spartan Micro’s SC 069 – Support Catheter Receives FDA 510k Clearance

Spartan Micro Receives Additional 510k Clearance

COSTA MESA, CALIFORNIA, UNITED STATES, May 16, 2022 /EINPresswire.com/ — —Spartan Micro, Inc., a developer of endovascular-based devices for use by interventional radiologists, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Spartan SC 069 support catheter.

The Spartan SC 069TM is an intermediate catheter designed for the introduction and support of interventional devices into the peripheral and neuro vasculature. It is available in three lengths and has access characteristics that may be useful in a variety of challenging anatomies. The latest in catheter technology was employed in the design of this new access tool.

The Spartan SC 069 is now offered alongside the Spartan MC 0165 microcatheter and the novel Spartan Center Wire (The Center Wire is for use in peripheral vasculature only).

“The foundation of an endovascular procedure is access to the treatment site. If your delivery system is less than optimal, your procedure may suffer. This is why Spartan Micro is focused on bringing the latest in catheter and access technology to the endovascular physician. Access devices must constantly evolve just as therapeutic devices do. Spartan Micro has shown it can rapidly respond to physician feedback, develop, and bring to market new solutions for the endovascular physician and their patients. We aim to evolve with the physician hand in hand.” – Eric Stoppenhagen, CEO, Spartan Micro

More information can be found on www.spartanmicro.com.

About Spartan Micro

Spartan Micro is a neuro and peripheral vascular medical device company based in Costa Mesa, California. Spartan fills the innovation gap abandoned by dominant medical device players. Our products are designed to optimize the delivery of the latest therapeutic devices, making it possible to go further and (safely) treat in the distal anatomy. Pipeline products include embolic solutions and therapeutic devices for ICAD.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction.

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Spartan Micro, Inc.
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Article originally published as: https://www.einpresswire.com/article/572547221/spartan-micro-s-sc-069-support-catheter-receives-fda-510k-clearance

The post Spartan Micro’s SC 069 – Support Catheter Receives FDA 510k Clearance appeared first on Advanced Primitive.

This news story originally appeared at Technology - Advanced Primitive on16 May 2022