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Point: A federal shield law is needed to protect the pressIRVINE, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering from venous and other vascular diseases, announced today that on December 1, 2024, it received national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its ClotTriever Thrombectomy System for DVT. This announcement follows the regulatory approval of the ClotTriever system by the Pharmaceuticals and Medical Devices Agency (PMDA) in December 2023. Due to ClotTriever’s unique mechanism of action for complete, wall-to-wall thrombus removal in patients suffering from DVT, MHLW created a new functional category that is separate from other catheter-based therapies. This new functional category comes with a reimbursement premium based upon ClotTriever’s wealth of clinical data showing safety and efficacy in removing various types of thrombi. To facilitate commercialization of the ClotTriever system in Japan, Inari has entered into a distribution agreement with Medikit Co., Ltd., a market leading vascular medical device manufacturer serving Japan, the U.S. and over 30 other countries. With this new partnership, Inari plans to accelerate initiation of its 100-patient Post Market Surveillance study, followed by broader commercial expansion. “MHLW’s approval of reimbursement for ClotTriever under a newly designated functional category marks a transformative milestone for Inari in Japan,” said Drew Hykes, Chief Executive Officer of Inari. “This decision underscores the value of ClotTriever in addressing unmet clinical needs, and we are thrilled to collaborate with Medikit to bring this innovative solution to Japanese DVT patients, improving lives and advancing care in the near future. Over time, we look forward to bringing our broader portfolio of purpose-built tools to the Japanese market.” The ClotTriever system is 510(k)-cleared by U.S. FDA and CE-Marked for treatment of DVT. More than 75,000 procedures have been conducted with ClotTriever globally. Recently, two-year outcomes were reported from the 500-patient ClotTriever CLOUT Registry showing a strong safety profile, significant clot removal, and low rates of post-thrombotic syndrome.1,2,3 ClotTriever is the most studied thrombectomy device for DVT, including the ongoing Randomized Controlled Trial, DEFIANCE, comparing ClotTriever to anticoagulation alone for patients with DVT.4 About Inari Medical, Inc. Patients first. No small plans. Take care of each other. These are the guiding principles that form the ethos of Inari Medical. We are committed to improving lives in extraordinary ways by creating innovative solutions for both unmet and underserved health needs. In addition to our purpose-built solutions, we leverage our capabilities in education, clinical research, and program development to improve patient outcomes. We are passionate about our mission to establish our treatments as the standard of care for venous thromboembolism and four other targeted disease states. We are just getting started. Learn more at www.inarimedical.com and connect with us on LinkedIn , X (Twitter) , and Instagram . About Medikit Co., Ltd. Medikit Co., Ltd., based in Tokyo, established in 1973, is a global medical device company and is publicly traded on the Tokyo Stock Exchange (Code: 7749). Medikit’s mission is to deliver the highest standards of excellence in operating as a health care company whose products and services help to enhance healthy life by minimizing unnecessary suffering and death from disease. Medikit is a market leader in Japan in interventional products, including vascular access devices such as hemodialysis catheters, intravenous catheters, sheaths, and guiding catheters. Medikit products are sold in Japan, the United States, and over 30 other countries. The company has sales, R&D, and manufacturing capabilities with more than 1,300 consolidated employees. For more information, visit the company’s website at www.medikit.co.jp . Investor Contact: Neil Bhalodkar IR@inarimedical.com 1 Bisharat, et al. One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis. JSCAI. 2024. 2 Shaikh, et al. Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry. Cardiovasc Int Rad. 2023. 3 Dexter, D. Interim two-year outcomes from the fully enrolled CLOUT registry. Presented at AVF 2024 (Tampa, FL). 4 Abramowitz, et al. Rationale and Design of the DEFIANCE Study: A Randomized Controlled Trial of Mechanical Thrombectomy Versus Anticoagulation Alone for Iliofemoral Deep Vein Thrombosis. American Heart Journal. doi.org/10.1016/j.ahj.2024.10.016
ST. SIMONS ISLAND, Ga. (AP) — Maverick McNealy steadied himself after a rugged start Saturday with a 4-under 66 and caught up with Vince Whaley in a wild third round at the RSM Classic in which a half-dozen players had at least a share of the lead. McNealy looked as though he might have the lead when he hit wedge on the final hole that rolled just by the cup and settled 8 feet away. He missed the putt, still in great position to go after his first PGA Tour victory. Whaley, also winless on tour, birdied the 18th for a 63 and will be playing in the final group for the first time on the PGA Tour. McNealy, who joined him at 14-under 198, also shared the 54-hole lead in 2021 at the season opener in Napa, California. Whaley was playing with a sense of freedom not everyone has at the final PGA Tour event this year. He was playing on a medical extension and fulfilled the necessary points in July. The next step was finishing in the top 125 in the FedEx Cup. He secured that last week with a tie for fifth in the Bermuda Championship. Everything else feels like a bonus, and there could be no greater perk than a victory to get into the Masters and PGA Championship, along with a two-year exemption. “I've really got nothing to lose and everything to gain, so I'm just excited for the opportunity,” Whaley said. Opportunity abounds going into the final round. Daniel Berger shot a 63 and played his way into the final group, just two shots behind. He was tied with former Sea Island winner Mackenzie Hughes of Dundas, Ont., (65), Michael Thorbjornsen (67) and Patrick Fishburn (69). Adam Hadwin of Abbotsford, B.C., (71) dropped 23 spots to tie for 47th at 3 under. Adam Svensson of Surrey, B.C., (70) was 1 under. Berger and Thorbjornsen were among those who arrived at Sea Island outside the top 125, the number required to keep full status on tour on next year. Thorbjornsen already has that locked up as the No. 1 player in the PGA Tour University ranking. Berger needed a big week and he's delivering, even though he says he doesn't feel stress. Berger missed 19 months with a back injury that he feared might end his career. Now he's healthy enough to have played 27 times this year. “Regardless when I play well, I'm going to be fine,” said Berger, who played in the 2021 Ryder Cup at Whistling Straits. "When you miss that much amount of time it takes a little bit of a while to get back. It's just a matter of being patient and eventually good things come around.” Henrik Norlander and Hayden Springer, also on the wrong side of No. 125, each shot 63 and were among those tied for 12th, a position that currently would let them move into the top 125. Joel Dahmen, who had to make a 5-foot par putt on Friday to make the cut, shot 70 and was tied for 61st. He is at No. 124 and his future depends on a big round Sunday, along with how Thorbjornsen, Berger, Norlander and Springer fare. Closer to the top, eight players were separated by three shots. That includes Luke Clanton, the Florida State sophomore and No. 1 amateur in the world who already has three top-10 finishes on the PGA Tour and was going after another one. ___ AP golf: https://apnews.com/hub/golf The Associated PressHandshakes and hugs as Cardin bids Senate farewell: ‘He put substance over flash’
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( MENAFN - Asia Times) This article was originally published by Pacific Forum. It is republished with permission. Vietnam's maritime security is shaped by its geographic position, strategic interests, and the pressing need to safeguard its territorial waters. The South China Sea (known in Vietnam as the East Sea) serves as a crucial route for international trade. It is also marked by intricate territorial disputes, highlighting the importance of Vietnam's naval and coast guard forces. China's growing fleet of unmanned air, surface, and underwater systems poses a serious security threat to Hanoi. In August 2024, a Chinese WZ-10 drone entered Vietnam's airspace 160 to 170 kilometers from Cam Ranh, a vital naval base. The Chinese have raised the temperature in the South China Sea by using unmanned underwater vehicles (UUVs), gliders and Argo floats , which are dual-use. This has prompted Vietnam to seek measures to enhance its monitoring, patrolling, and response capabilities without overcommitting its limited conventional forces. A key opportunity to bolster these efforts is integrating unmanned systems into Vietnam's defense arsenal. Given the existing capacity shortfalls, Quadrilateral Security Dialogue (“Quad”) nations, which have a plan to support capacity-building for regional navies in Southeast Asia, are well-positioned to enhance Vietnam's capabilities in this area. The Vietnamese People's Army (VPA) has extensive experience operating UAVs to augment its maritime intelligence, surveillance, and reconnaissance (ISR) capabilities. These UAVs are either domestically developed with foreign assistance or imported from abroad. Vietnam also showcased its larger class of UAVs, conceivably a medium-altitude long-endurance system, during its first international defense expo in 2022. However, Vietnam's focus on unmanned maritime vehicles, both surface and underwater, is still in a nascent stage. As tensions in the maritime domain with China escalate, the VPA seeks advanced unmanned surface vehicles (USVs) and UUVs to bolster its maritime security and protect critical maritime infrastructure in the Vietnamese EEZs. These systems not only are cost-effective but they also play a crucial role in ISR capabilities. The Quad is now more strategically aligned and is recognized as a valuable platform for fostering regional cooperation that aims to enhance peace and stability in the Indo-Pacific. The September 2024 Quad joint statement explicitly highlights the importance of strengthening maritime security capabilities of Southeast Asian nations. Vietnam, given its robust ties with the Quad countries, has much to gain from partnering with the Quad, particularly in improving its technological and operational prowess in maritime security. The Quad nations have expertise in developing and operating unmanned maritime systems. Sharing technological knowledge or co-developing specialized systems tailored to Vietnam's requirements would substantially help its ISR capabilities. In particular, India and Vietnam maintain close defense ties, given that both use Soviet weapon systems. During Vietnamese Prime Minister Pham Minh Chinh's state visit to India in August 2024, both nations reiterated their commitment to strengthening mutual relations. India has provided a $300 million loan to Hanoi for acquiring two types of patrol vessels. In addition, the US has supplied the Vietnam Coast Guard with 18“Metal Shark” patrol boats, while Japan is offering a $348 million loan to Hanoi for constructing six patrol boats, set to be operational by 2025. There is potential for industrial collaboration, which could lead to a joint venture in constructing UUVs or USVs that would be advantageous for both nations. Defense industry cooperation to develop unmanned maritime systems presents a significant opportunity for the Quad nations to collaborate with Hanoi. This can include building or upgrading command-and-control infrastructure to ensure seamless operation and coordination. Additionally, supporting Vietnam in building a domestic unmanned maritime systems industry, potentially through technology transfers and specialized human resource training, could foster greater autonomy and capability in Vietnam's defense sector. While the potential benefits of unmanned systems are clear, they are not without challenges. Vietnam's approach to security partnerships is carefully balanced to avoid over-reliance on any one partner. Vietnam aims to engage with the Quad, ensuring its non-alignment policy remains intact while maximizing cooperation benefits. Although unmanned systems are more cost-effective than manned alternatives, acquiring and maintaining these still entails significant investment. Vietnam may need to explore financing options with the assistance of Quad nations. Additional challenges include the absence of a comprehensive legal and regulatory framework for unmanned systems development and deployment in Vietnam. The collaboration in unmanned maritime systems may represent a significant advancement for Vietnam and the Quad. In conclusion, Vietnam's maritime security is a linchpin for regional stability and economic prosperity. As maritime threats grow more sophisticated, integrating unmanned maritime systems into its strategy will provide a critical edge for VPA. With its collective technological expertise and strategic interest in a free and open Indo-Pacific, the Quad can play a pivotal role. By focusing on technology transfer, training, infrastructure support, and joint exercises, the Quad can help build Vietnam's capacity to protect its waters. While Vietnam maintains a non-aligned stance, its advocacy for a rule-based order and its reliance on international law to safeguard its maritime interests make it a natural partner for the Quad. Strengthening Vietnam's maritime capabilities will therefore greatly enhance regional security and also underscore the Quad's commitment to safeguarding the shared interests of Southeast Asian countries. Prakash Panneerselvam, PhD, (... ) is a Japan Foundation Indo-Pacific Partnership (JFIPP) research fellow and an assistant professor at the National Institute of Advanced Studies (NIAS), Bengaluru. Van T. Pham, rer, (... ) is founding director of the South China Sea Chronicle Initiative in Vietnam. Thank you for registering! An account was already registered with this email. Please check your inbox for an authentication link. MENAFN19122024000159011032ID1109014646 Legal Disclaimer: MENAFN provides the information “as is” without warranty of any kind. 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