Uptake Medical Release: Intervapor Targeted Ablation Therapy Reported As Superior To Standard Medical Management In The Lancet
-- Journal Article Reports Statistically Significant Improvements for Severe Emphysema Patients During STEP-UP Trial --
LONDON--(BUSINESS WIRE)--Medical technology innovator Uptake Medical announced today that patients with severe emphysema who underwent bronchoscopic lung volume reduction performed with the company’s InterVapor® targeted therapy experienced statistically significant and clinically meaningful benefits in both lung function and quality of life, according to an article published today in The Lancet.
“Segmental Volume Reduction Using Thermal Vapour Ablation in Patients With Severe Emphysema: 6-month Results of the Multicentre, Parallel-Group, Open-Label, Randomised Controlled STEP-UP Trial”
The article, “Segmental Volume Reduction Using Thermal Vapour Ablation in Patients With Severe Emphysema: 6-month Results of the Multicentre, Parallel-Group, Open-Label, Randomised Controlled STEP-UP Trial,” reported clinical details for patients participating in the STEP-UP (Sequential Staged Treatment of Emphysema with Upper Lobe Predominance) trial. The randomized, controlled, multi-center, multi-national study was designed to evaluate the safety and performance of the InterVapor system.
Seventy (70) adult patients between the ages of 45-75 were enrolled in the STEP-UP trial, which was conducted at 13 medical institutions in Europe and Australia. All patients were randomized to either treatment or control arms, and had severe upper lobe-predominant emphysema and a forced expiratory volume (FEV1) between 20% and 45%.
Patients receiving the InterVapor treatment had a mean relative improvement in FEV1 (lung function) of 10.1 percent at three months, which increased to 14.7 percent at the six-month mark. Their health-related quality of life (using St. George’s Respiratory Quotient or SGRQ-C), showed a 9.7-point improvement. The authors reported that overall, treated patients’ FEV1, forced vital capacity, and residual volume all showed statistically significant (p<0·05) between-group improvements at six months.
“Non-surgical bronchoscopic lung volume reduction has gained clinical traction because the interventions are minimally invasive, with reduced mortality and morbidity when compared to traditional lung volume reduction surgery,” said Prof. Felix Herth, the article’s lead author, interventional pulmonologist of the Thoraxklinik, and co-principal investigator of the STEP-UP study.
“The STEP-UP study, which involved a staged treatment strategy targeting only the more diseased segments of an upper lobe, has shown that bronchoscopic lung volume reduction as a treatment approach leads to statistically and clinically significant improvements compared with standard care. It allows for precise targeting of only the more diseased segments of a lobe, and enables clinicians to take a personalized approach to treating a patient’s most diseased segments at the initial stage, assessing their response, and then considering further treatment on an individual basis,” Prof. Herth concluded.
“The publication of these groundbreaking clinical results in The Lancet is just the latest reaffirmation of InterVapor as a safe and effective treatment option for severe emphysema patients. The article’s authors note that other lung volume reduction therapies may decline in effectiveness over time, but InterVapor’s targeted vapor ablation therapy leads not only to clinically meaningful improvements, but the potential for additional future treatments to help patients suffering from this progressive, debilitating condition,” said King Nelson, president and CEO of Uptake Medical.
About InterVapor and Uptake Medical
Uptake Medical is a privately held company focused on the treatment of lung cancer and emphysema without the risks of surgery and implants or the toxicity of radiation. InterVapor, Uptake’s proprietary targeted vapor ablation technology that received CE Mark approval in 2015, applies energy with heated water vapor via a standard bronchoscope to the lungs. In the 15-minute procedure, lung tissue ablation is performed on the more diseased lung segments. The healthier segments are preserved to provide lung function and quality of life improvements in emphysema patients and to provide potential future targets as the disease inevitably progresses.
The InterVapor platform is now being tested and validated as a possible treatment for lung cancer tumors in a first-in-human study of regional lung tumor ablation in patients with early stage lung cancer and lung metastases. The outside-in bronchoscopic approach eliminates the need for percutaneous access or the need to pierce the tumor in a 10-second ablation during a 15-minute procedure. Founded in 2005, Uptake Medical is located in Tustin, California.