Penumbra, Inc., a global interventional therapies company, today announced the U.S. launch of its new POD® Packing Coil, designed to be used as a complementary device with Penumbra’s Ruby® and POD (Penumbra Occlusion Device) embolization products. This latest launch adds to the company’s rapidly expanding peripheral vascular product portfolio. Nearly 900,000 Americans each year suffer from peripheral vascular conditions involving acute clots or aneurysms that occur outside the brain or heart, and this represents a large and growing patient population.

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Penumbra has developed a suite of thrombectomy and embolization products for use in a range of peripheral vascular conditions, and these products are driving significant growth:

  • Penumbra’s embolization platform includes Ruby and POD and the new POD Packing Coil, which is uniquely designed to pack very densely behind Ruby and POD to occlude arteries and veins throughout the peripheral vasculature, including aneurysms.
  • Penumbra’s next-generation Indigo® System is a continuous aspiration thrombectomy device designed to remove fresh, soft emboli and thrombi from the peripheral arteries and veins. The Indigo System includes four catheter sizes (CAT 3, 5, 6 and 8). The aspiration lumen is paired with a proprietary continuous vacuum aspiration pump to evacuate clot effectively and efficiently.

“With the Indigo System and POD, Penumbra has recently introduced products that have had significant impact on the treatment of vascular disease. Indigo represents a significant advancement in the treatment of thrombotic and embolic disease, which until now has had limited treatment options,” said Corey Teigen, MD, at Sanford Health in Fargo, ND, who uses Penumbra’s peripheral vascular products. “With the Indigo System, physicians now have the ability to remove limb- and life-threatening clots quickly and efficiently. Likewise the POD, Ruby and now the POD Packing Coil optimize embolization procedures by decreasing procedure time while providing increased control.”

“Our embolization platform and the Indigo System are examples of our commitment to innovating new technologies for challenging vascular conditions for which there are significant unmet clinical needs,” said Adam Elsesser, Chairman and CEO of Penumbra. “We are intent on changing treatment paradigms to improve clinical outcomes across two large and growing markets: neuro and peripheral vascular.”

About Peripheral Vascular Disease

Peripheral vascular disease includes blood clots or aneurysms that affect the vessels of the upper and lower extremities and all other parts of the body except the brain and heart. There are nearly 900,000 people in the U.S. annually who suffer from acute clots or aneurysms in the body that may be treated by thrombectomy or embolization procedures.

Penumbra’s peripheral vascular product portfolio currently focuses on thrombectomy and embolization therapies:

  • Peripheral thrombectomy involves the removal of blood clots. There are an estimated 850,000 people in the U.S. who develop such conditions, and approximately 150,000 are treated per year with existing procedures including catheter-directed thrombolysis (clot-busting drugs).
  • Peripheral embolization involves obstructing blood flow to target vessels, aneurysms and vascular anomalies, and assisting with the treatment of oncological disease. There are approximately 50,000 patients treated each year in the U.S. for such conditions.

About Penumbra

Penumbra, Inc., headquartered in Alameda, California, is a global interventional therapies company that designs, develops, manufactures and markets innovative medical devices. The company has a broad portfolio of products that address challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets. Penumbra and the Penumbra logo are trademarks of Penumbra, Inc.

Forward-Looking Statements

Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; and potential adverse regulatory actions. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our prospectus dated September 17, 2015. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.

Source: Penumbra, Inc.