Food and Drug Administration approval is only the first step to medical device commercialization; device makers also need to obtain positive insurance coverage decisions from payers.
San Juan Capistrano-based Avenu Medical Inc. recently got both in the bag.
The medical device maker develops the Ellipsys Vascular Access System, a minimally invasive approach to the creation of an arteriovenous fistula, a surgical connection between an artery and a vein.
The system is used in patients with chronic kidney disease requiring hemodialysis.
The device received FDA clearance in June. Last month, it received Medicare HCPCS reimbursement C-code from the Centers for Medicare & Medicaid Services, effective next month. This provides payment for the Ellipsys procedure.
Avenu’s Ellipsys product costs $6,000 each.
“We are grateful to CMS for its foresight in creating a fair and reasonable reimbursement scenario,” said company co-founder and Vice President of Marketing Ed Chang in a statement.
“This will make vascular access for hemodialysis more widely available to the underserved ESRD patient population nationwide.” Kidney failure is also called end-stage renal disease.
Avenu’s device represents a significant advancement for dialysis patients and clinicians, according to the company.
“The Ellipsys procedure replaces an incision with a needle puncture, surgical dissection with ultrasound imaging, and sutures with tissue fusion,” it said, pointing out that after the procedure, the patient leaves with just a Band-Aid.
“Ellipsys is truly revolutionary because it is a non-surgical fistula creation that can provide good vascular access while reducing the pain and suffering associated with traditional fistula surgery,” said Dr. Alexandros Mallios, a vascular surgeon of L’Institut Mutualiste Montsouris in Paris.
Chang co-founded Avenu in 2010 with President Mark Ritchart. The serial entrepreneurs are seasoned medical device executives, having founded several companies together, including Cayenne Medical Inc. and Opus Medical Inc. The former was acquired by Zimmer Biomet Holdings Inc. (NYSE: ZBH) in 2016, and the latter was bought by ArthroCare Corp., which is now a subsidiary of British firm Smith & Nephew following the purchase in 2014.
Avenu reported raising $13.1 million last year.
Changing Path
In an announcement that could have direct effects on Orange County’s vast and diverse base of medical device manufacturers, the FDA said it’s considering placing a 10-year limit on older predicates for medical devices seeking clearance via the 510(k) pathway. The move is part of a modernization plan for the 510(k)—adopted in 1976— which is used for clearance of low- to moderate-risk devices substantially equivalent to devices already on the market.
The proposed framework aims for “efficiently advancing beneficial technology to patients” based on “more modern safety and performance criteria,” according to a joint statement by FDA Commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health.
They said manufacturers seeking 510(k)s generally rely on comparative testing against existing devices to prove that the new device is as safe and effective as those.
“Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies,” the statement said.
Bits & Pieces
Costa Mesa-based Integrated Behavioral Health Inc., which provides managed behavioral health and employee assistance programs and services, recently added David Sockel as chief commercial officer. He has over 20 years of experience in the healthcare industry and most recently served as executive vice president of corporate and product strategy and chief revenue officer of online health insurance marketplace Connecture Inc. … Tustin-based Foothill Regional Medical Center’s pediatric subacute unit received an “above-average” rating by the Centers for Medicare & Medicaid Services. The 42-bed unit is the largest pediatric subacute program in OC and one of only about 10 in California. … Newport Beach-based Hoag Memorial Presbyterian Hospital announced its Hoag Breast Center was recognized as a certified quality breast center of excellence by the National Quality Measures for Breast Centers Program for the sixth consecutive year. It’s one of 57 facilities in the U.S. to receive the designation, and the first and only center in OC.
