Integra LifeSciences Obtains FDA Approval for Cardiac Application of CUSA Clarity System
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 12 2025
0mins
Source: NASDAQ.COM
FDA Clearance: Integra LifeSciences received U.S. FDA 510(k) clearance for its CUSA Clarity Ultrasonic Surgical Aspirator System, expanding its use to cardiac surgery for debridement during valve replacement and repair procedures.
Existing Approvals: The CUSA Clarity system is already approved for various surgical fields, including neurosurgery and orthopedic surgery, where it aids in the fragmentation and aspiration of soft and hard tissues.
Significance of Clearance: This new clearance is a significant milestone, allowing for the application of ultrasonic aspiration in delicate cardiovascular surgeries, supported by sufficient safety and performance data.
Upcoming Showcase: Integra will present the CUSA Clarity system at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on December 11-12, 2025, emphasizing its expanded role in cardiac care.
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Analyst Views on IART
Wall Street analysts forecast IART stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for IART is 12.33 USD with a low forecast of 10.00 USD and a high forecast of 14.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
0 Buy
2 Hold
4 Sell
Moderate Sell
Current: 10.880
Low
10.00
Averages
12.33
High
14.00
Current: 10.880
Low
10.00
Averages
12.33
High
14.00
About IART
Integra LifeSciences Holdings Corporation is a global medical technology company. The Company manufactures and sells medical technologies and products in two segments: Codman Specialty Surgical (CSS) and Tissue Technologies (TT). The CSS segment consists of technologies and instrumentation used for a range of specialties, such as neurosurgery, neurocritical care and otolaryngology. The CSS business consists of a portfolio of brands, such as Codman, DuraGen, DuraSeal, CUSA, Mayfield, Bactiseal, and Certas Plus, which are used for the management of multiple disease states, including brain tumors, traumatic brain injury, hydrocephalus and other neurological conditions. It provides instruments that are used in precision, specialty and general surgical procedures. The TT segment is focused on three main areas: complex wound surgery, surgical reconstruction and peripheral nerve repair. The TT segment offers skin and wound repair, plastics and surgical reconstruction products, and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Integra LifeSciences Faces Recall Due to Packaging Defects Linked to 11 Serious Injuries
- FDA Alert: The FDA has issued an early alert regarding potentially high-risk issues with Integra LifeSciences' MediHoney wound and burn care products, citing packaging and production failures that could lead to infection and compromise patient safety.
- Product Recall: Integra has notified customers to immediately cease the use of all MediHoney wound and burn products and specific lots of CVS Wound Gel, ensuring these products are removed from clinical settings to prevent further harm.
- Injury Reports: As of December 19, 2025, Integra reported 11 serious injuries linked to MediHoney products and three serious injuries associated with CVS Wound Gel, highlighting the severity of safety concerns despite no reported fatalities.
- Distributor Instructions: Integra instructed distributors to halt further distribution of affected products and manage customer communications directly, ensuring that impacted products are properly handled, reflecting the company's commitment to customer safety.
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Integra LifeSciences CEO to Present at 44th Annual J.P. Morgan Healthcare Conference
- Conference Participation: Integra LifeSciences CEO Mojdeh Poul and CFO Lea Knight will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, showcasing the company's latest advancements in medical technology, which is expected to attract investor interest.
- Live Webcast: The presentation will be available via live webcast on Integra LifeSciences' investor relations website, enabling global investors to access real-time updates on the company, thereby enhancing transparency and investor confidence.
- Company Mission: Integra LifeSciences is committed to restoring patients' lives through innovative treatment pathways, demonstrating its leadership in surgical, neurologic, and regenerative care, which further solidifies its competitive position in the market.
- Brand Portfolio: The company offers a comprehensive portfolio of high-quality leadership brands aimed at meeting the evolving market demands through continuous innovation and high standards of medical solutions, driving long-term growth.
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