**Evaluating the Effectiveness of FDA Pre-Submission Meetings** The U.S. Food and Drug Administration (FDA) plays a pivotal role in ensuring...

# Evaluating the Value of FDA Pre-Submission Meetings: Are They Worth the Time? The U.S. Food and Drug Administration (FDA)...

**Evaluating the Value of FDA Pre-Submission Meetings** In the complex and highly regulated world of medical device and pharmaceutical development,...

**Implementing Shift Left Strategies in Software as a Medical Device (SaMD) Development: An Informative Webinar** In the rapidly evolving landscape...

**The Growing Importance of Cybersecurity in Healthcare: Addressing an Evolving Challenge** In recent years, the healthcare industry has undergone a...

**The Role of Technology in Enhancing Personalized Brain Health and Improving Outcomes: Insights from Mark Lehmkuhle, PhD, CEO and Founder...

# Common Materials and Devices in Medical Device Manufacturing Medical device manufacturing is a highly specialized field that requires stringent...

**HeartFlow Launches Advanced Interactive Plaque Analysis Platform for Evaluating Patient Risk in Suspected Coronary Artery Disease** *Medical Device News Magazine*...

# A Look Inside Canary Wharf’s Advanced Infectious Disease Testing Facility In the heart of London’s bustling financial district, Canary...

**Bon Secours Mercy Health and Philips Announce Long-Term Strategic Partnership** In a significant move poised to reshape the landscape of...

**Bon Secours Mercy Health and Philips Announce Multi-Year Strategic Partnership** *Medical Device News Magazine* In a significant move poised to...

**Novocuff Secures $26 Million in Oversubscribed Series A Funding to Enhance Preterm Birth Prevention Technology** *Medical Device News Magazine* In...

# 9 Innovative Applications of AI in Medical Device Development Artificial Intelligence (AI) is revolutionizing various sectors, and the field...

**Ideal Medical Solutions Honored at 2024 Medical Device Network Excellence Awards** In a remarkable celebration of innovation and excellence in...

**Government Initiates Program to Enhance Local Production of 113 Cost-Effective Medical Devices, Aiming to Reduce Import Reliance** In a significant...

**Digestiva Secures $18.4 Million in Series A Funding – Reported by Medical Device News Magazine** In a significant development within...

**Mabwell Gains NMPA Approval for Clinical Trial of Innovative Nectin-4 Targeting ADC in Triple-Negative Breast Cancer** In a significant stride...

**Immediate Medicare Coverage Announced for Designated Medical Breakthrough Devices by Knobbe Medical** In a landmark decision poised to revolutionize the...

**WHO Introduces MeDevIS: A Cutting-Edge Platform for Worldwide Medical Device Information** In a significant stride towards enhancing global healthcare, the...

# Comprehensive EDA Guidelines on Recall Classification Rules | RegDesk In the realm of medical devices and pharmaceuticals, ensuring product...

# Guidelines on Recall Classification Rules by the EDA ## Introduction The European Medicines Agency (EMA) and the U.S. Food...

# Comprehensive EDA Guidelines for Initiating Product Recalls | RegDesk In the fast-paced world of product manufacturing and distribution, ensuring...

# Exploring the Limits of Our Molecular Understanding In the vast and intricate world of biology, the molecular level serves...

**Applications of Precision Medicine in Healthcare** Precision medicine, also known as personalized medicine, is revolutionizing the healthcare landscape by tailoring...

# Comprehensive Guide to Breathing Apparatus Manufacturing ## Introduction Breathing apparatuses are critical safety devices designed to provide respiratory protection...

**The Future of Continuous Glucose Monitors: Analyzing Global Expansion and US Market Dominance** Continuous Glucose Monitors (CGMs) have revolutionized diabetes...

**The Future of Continuous Glucose Monitors: Global Expansion and Dominance in the US Market** Continuous Glucose Monitors (CGMs) have revolutionized...

**Global Expansion and US Dominance in the Future of Continuous Glucose Monitors** Continuous Glucose Monitors (CGMs) have revolutionized diabetes management,...

# Guideline for On-Site Inspections Under China’s Good Supply Practice (GSP) Issued ## Introduction China’s pharmaceutical industry has been undergoing...

# Guidelines for On-Site Inspections Under China’s Good Supply Practice (GSP) Issued ## Introduction China’s pharmaceutical industry has seen rapid...

First Patient Successfully Treated in VAPOR 2 Pivotal Study for Water Vapor Ablation of Prostate Cancer, Announces Francis Medical

Francis Medical, a leading medical technology company, has recently announced the successful treatment of the first patient in the VAPOR 2 Pivotal Study for Water Vapor Ablation of Prostate Cancer. This groundbreaking study aims to evaluate the safety and efficacy of water vapor ablation as a minimally invasive treatment option for prostate cancer.

Prostate cancer is one of the most common types of cancer among men, with over 1.4 million new cases diagnosed worldwide each year. Traditional treatment options for prostate cancer include surgery, radiation therapy, and hormone therapy. However, these treatments often come with significant side effects and can have a negative impact on a patient’s quality of life.

Water vapor ablation, also known as Rezūm therapy, offers a promising alternative to traditional treatments. It is a minimally invasive procedure that uses targeted steam to ablate the cancerous tissue in the prostate gland. The procedure involves inserting a small device into the prostate through the urethra, which delivers controlled doses of steam to the affected area. The steam destroys the cancer cells while preserving the surrounding healthy tissue.

The VAPOR 2 Pivotal Study is a multicenter, randomized controlled trial that aims to assess the safety and effectiveness of water vapor ablation in treating localized prostate cancer. The study will enroll approximately 200 patients across multiple sites in the United States. Participants will be randomly assigned to receive either water vapor ablation or standard of care treatment, such as surgery or radiation therapy.

The primary endpoint of the study is the proportion of patients who achieve disease-free survival at 12 months. Secondary endpoints include quality of life measures, urinary symptoms, sexual function, and treatment-related adverse events. The study will also evaluate long-term outcomes, such as cancer recurrence rates and overall survival.

Dr. Neal Shore, Medical Director of the Carolina Urologic Research Center and principal investigator of the VAPOR 2 study, expressed his enthusiasm for this innovative treatment option. He stated, “Water vapor ablation has the potential to revolutionize the way we treat prostate cancer. It offers a minimally invasive alternative to surgery and radiation therapy, with the potential for fewer side effects and a quicker recovery time.”

The successful treatment of the first patient in the VAPOR 2 study marks a significant milestone in the development of water vapor ablation as a viable treatment option for prostate cancer. Francis Medical is committed to advancing the field of urology and improving patient outcomes through innovative technologies.

In conclusion, the VAPOR 2 Pivotal Study for Water Vapor Ablation of Prostate Cancer is an exciting development in the field of prostate cancer treatment. This groundbreaking study aims to evaluate the safety and efficacy of water vapor ablation as a minimally invasive alternative to traditional treatments. With the successful treatment of the first patient, Francis Medical is one step closer to providing prostate cancer patients with a potentially safer and more effective treatment option.