Tele: 561.316.3330
Breaking Medical Device News

Friday, October 15, 2021

HomeCLINICAL TRIALS, STUDIES, DATAIntersect ENT Announces FDA Approval of SINUVA™ Sinus Implant, a New In-Office...

Intersect ENT Announces FDA Approval of SINUVA™ Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps

The company reports SINUVA is placed during a routine physician office visit. SINUVA expands into the sinus cavity and delivers an anti-inflammatory steroid directly to the site of polyp disease for 90 days.

Results from a randomized clinical trial demonstrated a 63% relative reduction in bilateral polyp grade (a measurement of the extent of ethmoid polyp disease) for patients treated with SINUVA, compared to control.

Robert C. Kern, M.D., Chairman of Otolaryngology, Head and Neck Surgery at Northwestern University Feinberg School of Medicine, who served as national co-principal investigator of the pivotal study of the implant states, “SINUVA represents a much-needed breakthrough for the many nasal polyp sufferers who are seeking an effective treatment.”  He highlighted, “For many patients struggling to manage this disease, the current treatment approaches of repeat surgeries and high-dose oral steroids have significant limitations, and intranasal sprays and rinses rely heavily on patient compliance. I look forward to offering SINUVA to my patients.”

Nasal polyps are inflammatory growths along the lining of nasal passages or sinuses that can cause nasal congestion, infections and loss of sense of smell. Many people with chronic sinusitis and nasal polyps return to their ENT specialist with symptoms within the first year following initial treatment. Approximately 635,000 Americans have had previous sinus surgery and continue to see their ENT physicians for treatment of recurring symptoms.

Lisa Earnhardt, president and CEO of Intersect ENT commented, “For more than a decade Intersect ENT has been focused on developing innovative therapies for chronic sinusitis sufferers. We are pleased that the approval of SINUVA will give patients with recurrent nasal polyps a new option.”  She concluded, “This FDA approval – our fourth commercial product, and our first product to be regulated as a pharmaceutical – is an exciting milestone for our team. We look forward to introducing SINUVA to physicians across the country in the coming months as we work toward our second-quarter launch.”

The FDA submission for the SINUVA Implant was supported by the results of clinical studies of 400 patients, including the landmark RESOLVE II pivotal study. RESOLVE II met its co-primary efficacy endpoints, which included a statistically significant reduction from baseline in bilateral polyp grade (p=0.007) and a reduction from baseline Nasal Obstruction/Congestion score (p=0.007). Secondary endpoints achieving statistical significance through day 90 include the proportion of patients still indicated for repeat sinus surgery and improvements in sense of smell, sense of nasal congestion and percent ethmoid sinus obstruction.

The FDA did not require any post-approval clinical trials. Additional details can be found here.

Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected


Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

By using this website you agree to accept Medical Device News Magazine Privacy Policy