AHA In Brief: Novoste Beta-Cath
This article was originally published in The Gray Sheet
Executive Summary
Novoste Beta-Cath: Results from pilot 35-patient study of beta-emitting catheter for restenosis show improved minimum lumen diameter after six months, Spencer King, MD, Emory University, reports at the American Heart Association annual conference in Orlando, Florida. "The majority of patients actually had a slight increase in their size," he noted. MLD was .75 mm prior to treatment, 2.07 mm post treatment and 2.1 mm at six months follow-up. Patients received 12 gy, 14 gy, or 16 gy of radiation. Enrollment in a 27-center, 1,110 patient study of the Beta-Cath is ongoing, King says. Novoste expects to submit a premarket approval application upon completion of the ongoing clinical trials...
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.