Vascular Solutions LLC

泰利福医疗器械商贸（上海）有限公司报告，由于涉及特定型号、特定批次产品的IPN未在英国注册，无CE标识。生产商美国心血管介入器材有限公司 Vascular Solutions LLC对微导管Turnpike catheters（注册证编号：国械注进20213030098）主动召回。召回级别为三级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。 附件：医疗器械召回事件报告表 2023年1月16日美国心血管介入器材有限公司附件.pdf

Accomplished industry leader with over twenty years of experience building lasting relationships with global regulatory agencies and guidance in the total product lifecycle of medical devicesATLANTA, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women’s needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health, today announced the appointment of Christine Thomas, RAC, as senior vice president of regulatory and clinical affairs, effective October 10, 2022. Ms. Thomas has over 20 years of successful leadership in regulatory and clinical affairs, including global strategy development and operations, as well as executive responsibility for medical device companies such as GE Healthcare, Boston Scientific, Smiths Medical, and RTI Surgical. Ms. Thomas will be leading all regulatory and clinical efforts for the FemBloc and FemaSeed clinical programs at Femasys. “We are excited about the addition of Christine to the Femasys team and the years of regulatory and clinical expertise and leadership she brings for products throughout the development cycle through commercialization, and beyond,” said Kathy Lee-Sepsick, president, CEO and founder of Femasys Inc. “Christine embodies the qualities we look for in our leadership team and we are fortunate to have someone of her caliber join us as we continue to advance products to benefit women around the world.” Ms. Thomas added, “I am pleased to join the senior leadership team at Femasys as the company continues to progress its clinical pipeline and bring more novel products to the women’s health market. As senior vice president of regulatory and clinical affairs, I am excited for the opportunity to work with this great team to facilitate meaningful interactions with the Food and Drug Administration to ensure women everywhere can get access to the innovative products being advanced at Femasys.” Ms. Thomas most recently served as head of regulatory solutions providing FDA focused consultant expertise at IQVIA MedTech, a large clinical research organization that provides solutions and services to support the needs of the medical device and in vitro diagnostics industry. Prior to this, she was vice president of regulatory, clinical, and quality at RTI Surgical, a leading surgical implant supplier. Previously, Ms. Thomas served as vice president of regulatory and clinical at Cardiac Science Corp. and vice president of regulatory, quality, compliance, regulatory and clinical, and regulatory and design assurance over her tenure at Smiths Medical. She also served as vice president/head of regulatory at Vascular Solutions and regulatory manager in the emerging therapies division at AMS. Ms. Thomas has been the regulatory, clinical, and quality lead on multiple M&A opportunities for both divestiture of product lines and acquisitions for several companies. Ms. Thomas holds a B.S. in Education from University of Wisconsin-Whitewater and is currently in the Johns Hopkins University Master of Science program. Grant of Inducement Option In connection with the appointment of Ms. Thomas, Femasys has granted to Ms. Thomas, effective as of her first day of employment, an option to purchase 50,000 shares of Femasys common stock at an exercise price per share equal to the closing price of Femasys common stock on the grant date as reported by Nasdaq. This grant was approved by the Compensation Committee of Femasys’ Board of Directors and made as an inducement material to Ms. Thomas entering into employment with Femasys as contemplated by Nasdaq Listing Rule 5635(c)(4). The stock option will vest as to 25% of the shares underlying the stock option on the first anniversary of the commencement of employment, with the remaining shares vesting 25% each year over the following three years, subject to Ms. Thomas’ continued employment with Femasys. Femasys provides this information in accordance with Nasdaq Listing Rule 5635(c)(4). About FemasysFemasys Inc. is a biomedical company aiming to meet women’s needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health. Its two lead product candidates are FemBloc® permanent birth control and FemaSeed® localized directional insemination for infertility. The Company’s product for fallopian tube assessment by ultrasound, FemVue®, and FemCerv®, an endocervical tissue sampler, are currently being marketed in the United States. Femasys is also advancing FemCath™, an intrauterine catheter for selective evaluation of the fallopian tubes intended to be marketed alongside its other women-specific medical products in the physician’s office setting. To learn more, visit www.femasys.com or follow us on Twitter and LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our product candidates; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (the “SEC”) on March 24, 2022, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law. Contacts: InvestorsChuck PadalaLifeSci Advisors, LLC+1-917-741-7792chuck@lifesciadvisors.com MediaKarissa Cross, Ph.D.LifeSci Communicationskcross@lifescicomms.com Femasys Inc.Investor Contact:IR@femasys.com Media Contact:Media@femasys.com

November 8, 2021 Independent analysis includes Centers for Medicare & Medicaid Services (CMS) data from over 700,000 peripheral arterial and peripheral venous intervention patients Data demonstrate a 32% reduction in major adverse limb events, such as amputations, during lower extremity arterial intervention When iliofemoral venous* stenting was guided by IVUS, there was a 31% reduction in the composite outcome of repeat intervention, hospitalization or death, together with a reduced risk of stent thrombosis, embolization and stenosis First real-world study by the Smith Center for Outcomes Research shows the value of IVUS in broad peripheral vascular patient populations, emphasizing the importance of IVUS in optimizing patient care Amsterdam, the Netherlands –Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology and IVUS solutions, today announced the results of a new large-scale real-world analysis of Centers for Medicare & Medicaid Services (CMS) data on the health outcomes of peripheral vascular interventions guided by intravascular ultrasound (IVUS). The study was conducted independently by the Smith Center for Outcomes Research, with the results presented at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) meeting by Eric A. Secemsky, MD, Director of Vascular Intervention and Interventional Cardiologist at Beth Israel Deaconess Medical Center and Assistant Professor of Medicine at Harvard Medical School in Boston, Massachusetts. The study, supported by Philips, underlines the company's commitment to a strong evidence base for its innovations in the pursuit of better patient outcomes, enhanced patient and staff experiences, and lower cost of care. Numerous prospective studies have already shown the benefit of IVUS guidance in peripheral vascular interventions, making it a gold-standard imaging modality for this application. The new study results now show that the outcome observations from these prior studies apply directly to a broader peripheral arterial and peripheral venous intervention patient population, demonstrating strong support for the use of IVUS during peripheral interventions. “The results of this large-scale study demonstrate favorable long-term outcomes in peripheral vascular interventions when IVUS is used,” said Eric Secemsky, MD. “This analysis, combined with the recent appropriate use consensus on IVUS that was presented at VIVA in October, highlights a clear opportunity to improve health outcomes for millions of patients by broader and more routine implementation of the technology in clinical practice. This is a moment for us to further our efforts in saving lives and saving limbs.” Peripheral artery disease (PAD): a 32% reduction in major adverse limb events, including amputations, during lower extremity arterial interventions The study looked at Medicare beneficiaries aged 65 years or older who underwent lower extremity arterial interventions between January 1, 2016, and December 31, 2019. Among 697,794 interventions, the investigators found a 32% reduction in major adverse limb events, such as amputations, over a median 425 days of follow-up. These findings were consistent across disease states, including critical limb ischemia and non-critical limb ischemia, as well as arterial segments such as the iliac (hip area), femoropopliteal (upper leg area) and tibial (lower leg area). Peripheral artery disease develops when plaque builds up in the vessel wall and reduces blood flow to the limbs, most commonly the legs. It affects more than 8.5 million people in the USA [1]. PAD symptoms include recurrent fatigue, leg pain, and foot or leg wounds that do not heal or heal very slowly. Critical limb ischemia (CLI) is an advanced stage of PAD and is typically associated with high rates of cardiovascular events, amputations, and mortality. CLI patients have low survival rates, with 5-year mortality exceeding 50% [2]. Chronic venous disease (CVD): a31% reduction in repeat intervention, hospitalization, or death during iliofemoral venous stenting Separately, the investigators examined Medicare beneficiary data for patients treated between January 1, 2017, and December 31, 2019, in multiple clinical settings, including hospital in-patient settings, hospital outpatient centers, and private office-based clinics, involving 20,984 individual patients. Of these, 72% underwent stenting guided by IVUS. When IVUS was used, there was a 31% reduction in the composite outcome of repeat intervention, hospitalization, or death. In addition, IVUS use reduced the risk of stent thrombosis, embolization and stenosis. Chronic venous disease (CVD) is both a common and underappreciated problem impacting over 30 million Americans [3]. Advanced CVD impacts over 6 million people in the USA and iliofemoral venous obstruction costs as much as USD 3 billion per year for ulcer care in advanced presentations [4]. “We commend Dr. Secemsky and the Smith Center for Outcomes Research for this on-going study to simplify clinical procedures and improve clinical and patient outcomes,” said Chris Landon, Senior Vice President and General Manager Image Guided Therapy Devices at Philips. “We are committed to supporting evidence-based medical guidelines in pursuit of better patient outcomes. We believe that the ability of IVUS to deliver procedure optimization and confidence enhances patient and staff experiences and lowers cost of care.” First-ever global consensus for the appropriate use of IVUS in PVD interventions In October 2021, a team of clinical experts led by Eric Secemsky, MD, established the first-ever global, cross-specialty expert consensus for the appropriate use of IVUS in peripheral vascular disease interventions. This initiative was jointly supported by Philips and Boston Scientific. Today, healthcare providers’ use of IVUS in PVD interventions is not standardized and is therefore inconsistent. The new appropriate-use expert consensus may help establish global standards of care to adopt into guidelines and improve quality of care in PVD. To achieve consensus, the broad, multi-disciplinary group of global experts used a rigorous methodology. They conducted a systematic and comprehensive review of key clinical IVUS scenarios and decision-making processes before voting on the appropriate use consensus. Through this methodology, the group has established a clinical consensus to identify the optimal use of IVUS and potential knowledge gaps in order to set a standard across clinical specialties and drive positive outcomes for patients. Their findings were shared at a special symposium during Vascular Interventional Advances (VIVA) 2021. Intravascular ultrasound (IVUS) Philips is the global leader in IVUS solutions, which are part of the company’s comprehensive portfolio of systems, smart devices, software, and services for peripheral vascular disease aimed at helping clinicians decide, guide, treat, and confirm the right therapy for each patient during their procedure. Phased-array IVUS is an important imaging tool used during venous and arterial interventions. It provides the fast plug-and-play usability and high-fidelity image resolution needed for pre-procedural planning, intra-procedural guidance, and post-procedural optimization of therapy for patients. Using a miniaturized ultrasound transducer mounted on the tip of a catheter, it captures real-time images of vascular disease inside vessels, enabling physicians to standardize and improve procedure care for their patients. Additional workflow optimization is enabled by integrated suite offerings such as Philips’ Azurion 7 with IntraSight platform. *The venous at the hip joint where the veins from the left and right leg come together into the abdominal aorta [1] [2] Duff S, Mafilios MS, Bhounsule P, Hasegawa JT. The burden of critical limb ischemia: a review of recent literature. Vasc Health Risk Manag. 2019;15:187-208. Published 2019 Jul 1. doi:10.2147/VHRM.S209241 & [3] [4] Joost Maltha Philips Global Press Office Tel: +31 6 10 55 8116 Email: joost.maltha@philips.com Fabienne van der Feer Philips Image Guided Therapy Tel: + 31 622 698 001 E-mail: fabienne.van.der.feer@philips.com About Royal Philips Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 17.3 billion and employs approximately 78,000 employees with sales and services in more than 100 countries. News about Philips can be found at . Attachments Philips intravascular ultrasound (IVUS) imaging - 1 Philips intravascular ultrasound (IVUS) imaging - 2