Uptake Medical's InterVapor system for emphysema wins EU approval
29 September 2011
Uptake Medical has received the CE Mark (Conformité
Européenne) for its InterVapor System for the treatment of severe
emphysema. The company says it is the first endoscopic lung volume
reduction system that uses the body’s natural healing processes without
leaving foreign materials behind.
This announcement coincides with the presentation of the
six-month results from the worldwide, multi-center VAPOR trial at
the European Respiratory Society Annual Congress. The clinical trial
data shows significant improvement in breathing capacity, shortness
of breath, exercise capacity and quality of life. The results of
this trial were presented during clinical sessions at the European
Respiratory Society’s Annual Congress on Sunday, September 25, 2011
at 10:45 AM in Amsterdam.
Emphysema is a progressive disease in which the lungs are
permanently damaged. This leads to a condition called
hyperinflation, which impacts breathing function and forces patients
to take short, shallow breaths, severely impacting quality of life.
The InterVapor System was developed in response to the needs of
patients with severe emphysema and is designed to directly target
the hyperinflation in the lungs.
The VAPOR study was an open label, single-arm trial of InterVapor
(Bronchoscopic Thermal Vapor Ablation) in patients with upper lobe
predominant emphysema. Primary endpoints measuring lung function
improvement (FEV1) and health-related quality of life (St. George’s
Respiratory Questionnaire or SGRQ) achieved both statistical and
clinical significance at six months. Additionally, 83 percent of
patients met a combined endpoint for clinical improvement.
Efficacy was consistently demonstrated across all endpoints.
Secondary endpoints demonstrated that patients treated with the
InterVapor procedure have significant physiologic improvements
(including decreased hyperinflation and gas trapping) as well as
clinical improvements (reduced breathlessness and improved exercise
capacity). All treatments were performed successfully without
intra-procedural complications. Adverse events related to treatment
included a temporary increase in respiratory symptoms in some
patients, which generally resolved with standard medical management.
Clinical data supports a favorable risk/benefit profile for the use
of InterVapor in the treatment of patients with heterogeneous severe
Felix Herth, MD, Chief, Department of Pulmonary Medicine,
Thoraxklinik Heidelberg and primary investigator for the VAPOR
study, is enthusiastic about the InterVapor data. “In a progressive
and debilitating disease such as emphysema, it is important to show
improvement across multiple measures as each metric indicates a
different aspect of emphysema. A procedure that shows an 83 percent
improvement when looking at several endpoints should provide new
optimism for patients who are living with emphysema.”
InterVapor is a minimally invasive procedure which treats
hyperinflated parts of the lungs with heated water vapor. InterVapor
triggers the body’s natural healing process, gradually reducing the
treated portion of the lungs and increasing the ability to breathe
more fully. Unlike other approaches to lung volume reduction,
InterVapor requires no foreign materials to be left behind in the
lung which may require additional procedures.
King Nelson, President and Chief Executive Officer of Uptake
Medical, stated, “We are extremely pleased to have received the CE
Mark for InterVapor and continue to be encouraged by the positive
results from our InterVapor technology. As the only endoscopic lung
volume reduction procedure that uses a natural healing process
without leaving foreign materials in the lung, we believe that
InterVapor will play an important role in advancing treatments for
emphysema. We have a unique opportunity to help patients with severe
emphysema and we look forward to having the InterVapor System
available to physicians and their patients.”
Source: Uptake Medical