the case for innovation
There is a clinical need for innovation in medical devices for PAD. Current scoring balloon therapies are sub-optimal, time consuming and require large inventories. In-stent restenosis (ISR) and fracture rates are high. Current atherectomy systems are expensive, and there is continued pressure from institutions to reduce costs.
There are 12 million people in the U.S. and more than 30 million worldwide who suffer from PAD. Contributing factors to these numbers are the aging population, smokers and diabetics. Patients in these categories are five times at risk for limb amputation. The number of procedures is on the increase, with about 2.3 million in the U.S. and 4.8 million worldwide. We estimate that the device market in the U.S. alone is about $3.3 billion.
The FLEX Scoring Catheter® is a one-size-fits-all device engineered for safety and designed for ease of use. Because it can be used in many applications, the FLEX Catheter replaces multiple SKUs and saves money. It has been described by physicians as easy to use, ergonomically solid and easy to adopt. Benefits for the patient include no perforations, no embolization and excellent results at procedure completion. FLEX supports the explosive growth in drug-coated balloons and drug-eluting stents.
FDA CLEARANCE & CE MARK
FLEX has received FDA clearance and CE Mark approval and is available for sale in the U.S. and the E.U.
Peripheral Artery Disease (PAD)
Peripheral artery disease (PAD) is a narrowing of the peripheral arteries caused by atherosclerosis (hardening of the arteries). It most commonly affects the arteries of the pelvis and legs. More than 12 million people in the U.S. and more than 30 million worldwide are affected by PAD. Patients are five times more at risk for limb amputation if they are left untreated. According to the American Heart Association, by age 65 approximately 12–20% of the U.S. population will have PAD.
As people age, the risk of developing leg artery disease increases. People older than 50 have increased risk of developing the disease, and men have a greater risk than women. Other factors increasing the chances of developing PAD include:
- Information found on http://www.heart.org
Interventional Treatment options
In more severe cases of PAD, lifestyle changes and medication may not be enough to improve symptoms. If the disease has advanced, recommendations may be for surgical or minimally invasive treatments. The choice of treatment depends on the pattern and extent of blockages, as well as other factors such as general health and the presence of other medical conditions. Sometimes a combination of various procedures available may be required for the most favorable result.
Traditional treatment such as surgical bypass is effective, but invasive. Despite the recent availability of multiple new endovascular technologies for the treatment of PAD, angioplasty balloons have remained the most frequently used modality either as primary therapy or adjunctive therapy along with stents and other devices. This is due to their simplicity of use, safety, relatively low cost and the paucity of data in most subsets demonstrating any significant advantages.
Conventional balloons have certain limitations in the treatment of complex PAD affecting the femoral and popliteal segments. These include a high rate of uncontrolled dissections that may require bailout stenting, inadequate luminal expansion and a low primary patency rate requiring repeat revascularization. Specialty scoring and cutting balloons have been developed to help address some of the inadequacies associated with conventional balloon angioplasty.
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Chief Executive Officer
VENTUREMED GROUP, LTD.