Merit Medical Systems has received FDA breakthrough designation for its endovascular stent graft system, the company said Thursday.
The device, which Merit describes as a "flexible, self-expanding endoprosthesis" is designed to treat the narrowing of blood vessels of patients on chronic dialysis treatment.
The South Jordan, Utah-based manufacturer moved the device, called Wrapsody, into a clinical trial in end-stage renal disease patients last year.
Merit CEO Fred Lampropoulos suggested in comments on a recent call with investors he sees the device as an important part of his efforts to improve the fortunes of the business, which recently slashed its earnings outlook in response to another quarter that fell short of expectations.
He talked up the prospects of Wrapsody on a call that was overshadowed by Merit’s laundry list of current difficulties.
"Our third quarter results this year were also hampered by our decline in gross margin growth as a result of product sales mix, increased cost, foreign exchange, trade concerns, tariffs and Brexit," he said in prepared remarks.
Other challenges included the integration of the $100 million purchase of BD's soft tissue core needle biopsy products in 2018. The endoscopy devices line declined most sharply.
The company lowered its 2019 sales guidance from between $1.007 billion and $1.029 billion to a range of $986 million to $995 million.
Now, Merit stands to benefit from Wrapsody's breakthrough device designation, which makes it eligible for additional input from FDA, expedited review and, under incoming changes, a different reimbursement process.
The 30-subject trial of Wrapsody is assessing the safety of the stent graft, while also gathering evidence of its ability to keep arm and thoracic central veins open. Merit started a second trial earlier this year to evaluate Wrapsody in iliac artery occlusive disease.
In a press release Thursday, Merit said it's approaching completion of its first-in-man studies.