Irvine-based medical device maker Edwards Lifesciences Corp. has expanded the use of its Pascal system, securing a new indication from the U.S. Food and Drug Administration (FDA) to treat patients with tricuspid valve disease. The approval was granted on October 21. This expansion makes Edwards the only U.S. company to offer transcatheter repair and replacement therapies for both the mitral and tricuspid heart valves. The Pascal system was initially approved in 2022 for degenerative mitral regurgitation, a condition characterized by improper valve flap closure.
Edwards also announced that its Pascal Ace system received FDA approval. This device includes capture clarity capabilities designed to assist doctors in repairing leaking mitral valves without requiring open-heart surgery. The Pascal Ace system utilizes fluoroscopic markers to indicate when valve leaflets have been successfully grasped during the mitral repair procedure.
The Pascal system is part of Edwards’ transcatheter mitral and tricuspid therapies (TMTT) business unit, which the company identifies as its fastest-growing segment. The TMTT unit recorded $195.9 million in sales during the second quarter, marking a 43% increase from the previous year. Edwards Lifesciences has set a target of achieving more than $2 billion in TMTT revenue by 2030, with anticipated growth fueled by sales of its Pascal, Evoque, and Sapien M3 systems.
Looking ahead, Edwards plans to present one-year data from its Clasp trial, which studied the Pascal tricuspid system, at the Transcatheter Cardiovascular Therapeutics (TCT) conference. The conference is scheduled to take place from October 31 to November 2 in San Diego.
Separately, earlier this month, Edwards Lifesciences advised customers to remove specific Commander M delivery systems used with its Sapien M3 device. This recommendation followed three reports of balloon bursts associated with the systems, linked to one death and one serious injury. Edwards stated the action was a voluntary recall affecting four specific lots of the Commander M Delivery System, which is used exclusively with the SAPIEN M3 system. The company specified that these four lots represent less than 200 delivery systems. Edwards indicated that it is working to support customers in completing the product return and replacement process. Other lot numbers of the Commander M delivery systems are not affected by this recall and remain cleared for continued use, according to the agency.
In other Irvine business news, MDxHealth SA, a urology-focused precision diagnostics company, saw its shares tumble more than 65% following the release of its preliminary third-quarter results and the suspension of its full-year guidance. The company, which maintains dual headquarters in Belgium and Irvine, anticipates third-quarter revenue of $22.7 million. This figure is flat year over year on an adjusted basis, excluding revenue from Resolve mdx, a urinary tract infection diagnostic test. Resolve mdx was discontinued this year due to challenges related to reimbursement.
MDxHealth additionally suspended its full-year revenue guidance, which had previously been projected between $110 million and $115 million. The company's stock has declined more than 94% since the beginning of the year. At press time, shares were trading at 20 cents, reflecting a market capitalization of $19.7 million.
Founded in 2003, MDxHealth offers a portfolio of five noninvasive tests designed for prostate cancer detection. The company is identified as the fifth largest diagnostics company in Orange County, employing 160 individuals locally. MDxHealth is scheduled to report its full third-quarter results on November 12.
