When Sean Duffy co-founded Omada Health in 2011, the pursuit was to reinvent how people manage chronic disease.  

By 2015, Omada earned full recognition from the U.S. Centers for Disease Control & Prevention for company’s digital diabetes prevention program and in 2018 it began a clinical trial demonstrating more than 4% percent average weight loss in a year among users.  

Health Evolution interviewed Duffy about the inspiration behind Omada Health, what perspective clients should expect in the next 18 months, and the most difficult challenge he has overcome as a leader. ​

Read More: ​https://www.healthevolution.com/insider/innovator-ceo-profile-omada-healths-sean-duffy/

The FDA approved an expanded indication for a transcarotid stent system to include patients at standard risk for adverse events from carotid endarterectomy, according to a press release from Silk Road Medical.

Previously, the stent system (Enroute) was approved for use only in patients with anatomic or physiological criteria that put them at high risk for complications from more invasive surgical procedures.


“This is the first time in history that a stent-based approach has demonstrated noninferiority in stroke and death rates relative to CEA, with our transcarotid artery revascularization [TCAR] system offering the added benefit of significantly reduced cranial nerve injury risk,” Erica Rogers, president and CEO of Silk Road Medical, said in the release. “This label expansion levels a playing field once dominated by open surgical techniques, allowing an expanded number of patients and physicians access to the benefits of a less invasive treatment option.”

Read More: ​https://www.healio.com/news/cardiac-vascular-intervention/20220503/fda-expands-indication-to-standard-risk-patients-for-transcarotid-stent-system

May 2, 2022—Silk Road Medical, Inc. announced that the FDA approved expanded indications for the company’s Enroute stent for transcarotid artery revascularization (TCAR) to include patients at standard risk for adverse events from carotid endarterectomy (CEA). Previously, the stent was approved for use only in patients with anatomic or physiologic criteria that put them at high risk of complications from more invasive surgical procedures.

According to Silk Road Medical, the company had previously submitted a premarket approval supplement, which included data extracted from the Vascular Quality Initiative. The surveillance data included in the submission represented real-world outcomes in 20,264 patients considered at standard surgical risk.

Those data demonstrated that use of Silk Road Medical’s TCAR system is statistically noninferior in stroke and death outcomes to CEA, while showing a ninefold reduction in cranial nerve injury (2.7% vs 0.3%; P ≤ .001), reported the company.

Read More: ​https://evtoday.com/news/silk-road-medicals-enroute-tcar-system-approved-for-expanded-indication-of-standard-risk-patients