Steve Combes Email & Phone Number

Pittsburgh, Pa, Us

Coordinate clinical support for the enrollment of the MOTIV BTK Randomized Controlled Trial

United States

Support site recruitment and enrollment in the DEXTERITY AFP clinical trial treating inflammation in DVT.

Pittsburgh, Pennsylvania, United States

United States

Philips acquired Intact Vascular in September 2020.

International

Lead clinical site management team to enroll patients at US and European research sites for the TOBA II, TOBA II BTK and TOBA III IDE studies for Tack Endovascular System. Selected, trained and supervised 6 Clinical Site Managers in the US and 4 independent consultants in Europe.

Greater Pittsburgh Area

Train and provide technical assistance to investigators for MIMICS-2, a prospective, multi-center study to evaluate the safety and effectiveness of the BioMimics 3DTM Stent System in the femoropopliteal arteries of patients with symptomatic peripheral arterial disease. Provided protocol, patient selection and device training in Osaka, Japan for the Japanese clinical team.

United States

Train and provide technical assistance to investigators for the SENTRY clinical study, a prospective, multi-center study of the Novate Sentry Bioconvertible Inferior Vena Cava Filter.

Start up medical device companies, upon receiving FDA clearance to market their device, face the challenge of creating a sales team from scratch to approach a market that they have minimal knowledge of and exposure to. Semper Fi Medical provides a small team of seasoned medical device sales professionals that will quickly put the device in the hands of luminary physicians and hospitals across the US to measure acceptance of the new product.Based upon the feedback, we will recruit, hire, and train a sales team to launch the product. Semper Fi Medical can serve as either contractors of full time employees.

Mid-West And Eastern Us

Enrollment manager for the EASE study to evaluate the safety and effectiveness of the Phoenix atherectomy catheter, a minimally invasive device for the treatment of peripheral arterial disease (PAD) in the legs. EASE (Endovascular Atherectomy Safety and Effectiveness) was an FDA approved Investigational Device Exemption (IDE) clinical trial that enrolled 90 patients at 20 clinical sites.Trained investigators to successfully screen and treat PAD patients with the Phoenix atherectomy device for Phase 1 clinical trial enrollment.

Cardiovascular Systems Inc. (CSI) is comprised of a highly experienced, uniquely qualified team of experts experienced in the assessment, development and commercialization of medical devices for treating cardiovascular disease.In 2004, CSI began developing "orbital" technology with the goal of creating smooth, patent lumens in diseased vessels. In the years following, the company refined the technology to address the growing market need of providing a safer more effective atherectomy device, and the chance to shift the treatment paradigm to improve the quality of life for the 12 million Americans who suffer from PAD.

Managed 22 account executives and modality managers in Michigan, Ohio, New York, Pennsylvania, and West Virgnina selling cath labs, Cardiac CT, and Cardiac MRI systems.

Launched the Aspire covered stent and Moll Ring Cutter for remote endarterectomy for SFA stenosis. Recruited key opinion leaders to participate in an IDE study for SFA approval for the Aspire stent.

Sales and business development of the off pump coronary bypass and endoscopic vein harvesting market in Western NY, PA, and WV.

Participated in the launch of the Wallstent, the first self-expanding flexible stent to the market.

Served as a logistics officer in Beirut, Lebanon and Japan.

Clinical Research Associate, Medical Device Clinical Research, Certificate Of Completion

22.5 hours

Bs, Communications

Education record