​Route 92 Medical has announced the publication of initial results from the SUMMIT NZ clinical trial—a single-arm, multicentre, prospective trial evaluating its proprietary Monopoint operating platform.

Results from the first 45 patients demonstrated that the Monopoint platform yielded an 80% first-pass effect with primary use of the HiPoint 88 (0.088-inch internal diameter [ID]) catheter, which is a super-bore catheter designed to consistently reach the proximal middle cerebral artery (MCA). The Route 92 HiPoint 88 aspiration catheter successfully reached the proximal MCA (M1 segment) in 100% of the cases attempted, as per a company press release. These results have been published online in the Journal of NeuroInterventional Surgery.

“The Monopoint operating platform with HiPoint 88 catheters delivered a step change in first-pass efficacy in the SUMMIT NZ trial, signalling clear potential for improved patient outcomes given the importance of clearing thrombus to save time and save brain,” said James Caldwell (Auckland City Hospital, Auckland, New Zealand), the paper’s first author. “The platform is designed to improve catheter deliverability, offering the advantage of greater simplicity for the operating physician to efficiently perform thrombectomy for patients.”

Read More: ​​https://neuronewsinternational.com/route-92-publishes-data-demonstrating-80-first-pass-effect-with-novel-thrombectomy-system/

SAN MATEO, Calif., June 06, 2022 -- Route 92 Medical, Inc., a private medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the publication of initial results of the SUMMIT NZ clinical trial, a single-arm, multi-center, prospective trial evaluating the proprietary Monopoint operating platform. Results from the first 45 patients demonstrated that the Monopoint platform yielded an 80% first pass effect (FPE1) with primary use of the HiPoint™ 88 (.088in ID) catheter, a super-bore catheter designed to consistently reach the proximal middle cerebral artery (MCA). The Route 92 HiPoint 88 aspiration catheter successfully reached the proximal MCA (M1 segment) in 100% of the cases attempted. The results were published in the Journal of NeuroInterventional Surgery online2.

“The Monopoint operating platform with HiPoint 88 catheters delivered a step change in first pass efficacy in the SUMMIT NZ trial, signaling clear potential for improved patient outcomes given the importance of clearing thrombus to save time and save brain,” said Dr. James Caldwell, attending physician at Auckland City Hospital and the paper’s first author. “The platform is designed to improve catheter deliverability offering the advantage of greater simplicity for the operating physician to efficiently perform thrombectomy for patients.”

Read More: www.bakersfield.com/ap/news/route-92-medical-announces-publication-of-initial-summit-nz-clinical-trial-results/article_81496d9f-0f57-55e5-87ed-aead22a4883c.html

Chronic musculoskeletal pain has a vast global prevalence and economic burden. Conservative therapies are universally recommended but require patient engagement and self-management to be effective. This study aimed to evaluate the efficacy of a 12-week digital care program (DCP) in a large population of patients with chronic knee and back pain.
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​A longitudinal observational study was conducted using a remote DCP available through a mobile app. Subjects participated in a 12-week multimodal DCP incorporating education, sensor-guided exercise therapy (ET), and behavioral health support with 1-on-1 remote health coaching. The primary outcome was pain measured by the visual analog scale (VAS). Secondary measures included engagement levels, program completion, program satisfaction, condition-specific pain measures, depression, anxiety, and work productivity.


A total of 10,264 adults with either knee (n=3796) or low back (n=6468) pain for at least three months were included in the study. Participants experienced a 68.45% average improvement in VAS pain between baseline intake and 12 weeks. In all, 73.04% (7497/10,264) participants completed the DCP into the final month.

78.60% (5893/7497) of program completers (7144/10,264, 69.60% of all participants) achieved minimally important change in pain. The number of ET sessions and coaching interactions were both positively associated with improvement in pain, suggesting that the amount of engagement influenced outcomes.

Read More: ​https://www.hingehealth.com/10000-participant-clinical-study/

SUNNYVALE, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that the Centers for Medicare and Medicaid Services (CMS), through collaboration with the Society of Vascular Surgery’s Patient Safety Organization (SVS PSO) and their Vascular Quality Initiative (VQI), has expanded coverage for TCAR to include standard surgical risk patients within the VQI’s TCAR Surveillance Project (TSP). This decision is effective immediately and comes on the heels of the recent Food and Drug Administration (FDA) approval for expanded indications for the ENROUTE® Transcarotid Stent System to include patients at high risk and standard risk for adverse events from carotid endarterectomy (CEA).

“This CMS coverage expansion ensures that many more carotid artery disease patients who require treatment have the opportunity to benefit from the minimally invasive approach that our TCAR® system offers,” said Erica Rogers, President and Chief Executive Officer of Silk Road Medical. “We’re grateful to the teams at the FDA, CMS, and SVS for their valuable collaboration and partnership in recognizing the weight of real-world evidence supporting TCAR use in this expanded patient population and the necessity of working to prevent the debilitating impacts of stroke on individuals, their families, and the health system as a whole.”

Read More: ​https://www.globenewswire.com/news-release/2022/06/02/2455019/0/en/Silk-Road-Medical-Announces-Expanded-Medicare-Coverage-for-TCAR-in-Standard-Surgical-Risk-Patients.html

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

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

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

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