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Investing for Innovation

Taking action on prediabetes

6/2/2022

 
Via: Coverage
Healthy lifestyle changes, such as eating healthy food, and being active, can help – and now, there are new digital support options like Omada.

A prediabetes diagnosis offers a valuable opportunity to take action to protect your health, according to clinicians. 

“Type 2 diabetes is preventable,” said Dr. Carolyn Jasik, chief medical officer of Omada Health, a digital tool that helps individuals make behavioral changes that improve their health. “Patients who embrace lifestyle changes have a good shot at never developing diabetes.” 

Read More: ​https://coverage.bluecrossma.com/article/taking-action-prediabetes

Financial Trends in Digital Health, Future of Virtual-First Care

6/2/2022

 
Via: Population Health Learning Network
Wei-Li Shao, president of Omada Health, provides insight on financial trends in digital health investment, and what the virtual-first care approach means for the future of health care.

Welcome back to PopHealth Perspectives. A conversation with the Population Health Learning Network, where we combine expert commentary and exclusive insight into key issues in population health management and more.

Today, we are joined by Wei-Li Shao, President of Omada Health. He provides insight on financial trends in digital health investment, Omada's platform and funding, and what the virtual first care approach means for the future of health care.

Read More: ​https://www.hmpgloballearningnetwork.com/site/ihe/podcasts/financial-trends-digital-health-future-virtual-first-care

Innovator CEO profile: Omada Health’s Sean Duffy

5/16/2022

 
Via: Health Evolution
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/

FDA expands indication to standard risk patients for transcarotid stent system

5/3/2022

 
Via: Healio
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

Silk Road Medical’s Enroute TCAR System Approved for Expanded Indication of Standard-Risk Patients

5/2/2022

 
Via: Endovascular Today
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

Route 92 Medical® Announces First Patient Enrollment in the SUMMIT MAX Pivotal Clinical Trial for the Monopoint® Reperfusion System

2/8/2022

 
Via: GlobalNewswire
SAN MATEO, Calif., Feb. 08, 2022 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a private medical technology company dedicated to becoming the performance leader in acute ischemic stroke intervention, today announced the first patient enrollment in its SUMMIT MAX clinical trial. SUMMIT MAX is a randomized, controlled, multi-center trial to evaluate the performance of its next generation Monopoint Reperfusion System versus currently available aspiration catheter technology. The first patient was enrolled at Auckland City Hospital in New Zealand, followed shortly by a patient at West Virginia University Medicine in the United States.

"I am delighted to begin enrollment in the SUMMIT MAX Study,” said Dr. Ben McGuinness of Auckland City Hospital in New Zealand. “The early results from our initial experience with the Route 92 088 platform in the SUMMIT NZ Study demonstrated an 80% TICI 2b-3 first pass reperfusion rate. It is an exciting opportunity to evaluate the possibility of improving interventional stroke treatment, and I hope the results of this trial will benefit future stroke patients."

​Read More: ​https://www.globenewswire.com/news-release/2022/02/08/2380790/0/en/Route-92-Medical-Announces-First-Patient-Enrollment-in-the-SUMMIT-MAX-Pivotal-Clinical-Trial-for-the-Monopoint-Reperfusion-System.html

WVU Rockefeller Neuroscience Institute first in U.S. to enroll patient in stroke clinical trial

2/8/2022

 
Via: WVUMedicine
MORGANTOWN, W.Va. – The WVU Rockefeller Neuroscience Institute was first institution in the United States to enroll a patient in the Route 92 Medical, Inc. SUMMIT MAX clinical trial. SUMMIT MAX is a randomized, controlled, multicenter trial to evaluate the performance of its next generation Monopoint™ Reperfusion System versus currently available aspiration catheter technology. 

Device illustration

The trial’s first patient was enrolled at Auckland City Hospital in New Zealand, followed shortly by a patient at the WVU Rockefeller Neuroscience Institute. 

“We are happy to become the first U.S. site to enroll a patient in the SUMMIT MAX clinical trial evaluating the Monopoint System,” Ansaar Rai, M.D., WVU Rockefeller Neuroscience Institute professor and Neuroradiology Department chair, said. “Randomized clinical trials such as these offer high levels of evidence and are critical in advancing the field of endovascular stroke therapy.”

Read More: ​https://wvumedicine.org/news/article/wvu-rockefeller-neuroscience-institute-first-in-u-s-to-enroll-patient-in-stroke-clinical-trial_0/

Omada Health – How Companies Can Help Employees Manage Chronic Health Conditions with Sean Duffy

1/21/2022

 
Via: RecruitingDaily 
On today’s episode of the RecruitingDaily Podcast, William Tincup speaks with Sean Duffy, co-founder and CEO at Omada Health about how companies can help their employees manage chronic health conditions.

Omada Health is a virtual care provider that specializes in disease areas where a virtual first approach is the best approach for both the person and to pull costs out of the healthcare system. They specialize in chronic health conditions such as: pre-diabetes, diabetes, hypertension, mental health, and musculoskeletal disease for people suffering from muscle and joint pain.

"A lot of people have forgone needed care during the pandemic, which is a huge problem. That’s where we’re so proud of what we do at Omada, that in the context of a world where it’s not easy for people to go in and get the care they need, we have to bring it to them. COVID really illustrated that need."

​Read More: ​https://recruitingdaily.com/podcast-episode/omada-health-how-companies-can-help-employees-manage-chronic-health-conditions-with-sean-duffy/

Early Evaluation of Transcarotid Artery Revascularization (TCAR) Versus Carotid Endarterectomy (CEA) Cost-Effectiveness

12/27/2021

 
Via: GlobalNewswire
Rosemont, Ill., Dec. 27, 2021 (GLOBE NEWSWIRE) -- A cost-effectiveness model based on peer-reviewed sources suggests that although five-year costs for transcarotid artery revascularization (TCAR) were higher than those for carotid endarterectomy (CEA), TCAR afforded greater quality-adjusted life years (QALY).

The study is published in the December 2021 issue of the Journal of Vascular Surgery.

Stroke is the fifth leading cause of mortality in the United States, accounting for one in every 19 deaths. Carotid artery disease causes up to 20% of strokes. Since its development in the 1950s, carotid endarterectomy has been the “gold standard” surgical therapy for the treatment of carotid disease. With the advent of endovascular technology in the 1990s, carotid angioplasty and stenting (CAS) emerged as an alternative mode of revascularization.

According to principal author Mahmoud Malas, MD, from the University of California, San Diego, “TCAR was developed to address the deficiencies associated with both CEA and TFCAS. Several studies have shown that TCAR has one-half the stroke rate of TFCAS. Further, it has similar stroke and death outcomes compared with CEA while reducing the incidence of cranial nerve injury and myocardial infarction.”

Read More: ​https://www.globenewswire.com/news-release/2021/12/27/2358053/0/en/Early-Evaluation-of-Transcarotid-Artery-Revascularization-TCAR-Versus-Carotid-Endarterectomy-CEA-Cost-Effectiveness.html

TCAR associated with “promising early and late outcomes”, pooled data suggest

5/28/2021

 
Via: VascularNews
A systematic review and meta-analysis has found that transcarotid artery revascularisation (TCAR) is associated with “promising early and late outcomes” in patients with internal carotid artery stenosis, although symptomatic patients still carry a higher risk of early cerebrovascular events. This is the conclusion of George C Galyfos (Hippocration Hospital, Athens, Greece) and colleagues, whose work was published as an Editor’s Choice paper in the European Journal of Vascular and Endovascular Surgery (EJVES).

The authors state that either carotid endarterectomy (CEA) and transfemoral carotid stenting (tfCAS) are usually recommended for the treatment of significant carotid stenosis. However, they note that both techniques have certain limitations. “Open surgery is associated with higher surgical stress, and could be the cause of the higher cardiac risk compared with stenting,” they elaborate, while tfCAS, on the other hand, carries the risk of intraoperative embolisation and chronic renal insufficiency, among others.

“[TCAR] offers an alternative strategy in patients where CEA or transfemoral stenting face difficulties,” Galyfos et al write. This review aimed to evaluate pooled data on patients undergoing TCAR and—in contrast to other similar reviews— evaluates both early and late outcomes as well as the effect of preoperative symptoms on early stroke/transient ischaemic attach (TIA), the authors detail.

Read More: ​https://vascularnews.com/tcar-associated-with-promising-early-and-late-outcomes-pooled-data-suggest/
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