DR. BAAL MedDev Consultant

Clinical Research with Medical Devices

References:

Letter of Recommendation Prof. Stypmann, January 2016
Letter_of_Recommendation_TBaal_from_Prof_Stypmann.pdf (299.77KB)
Letter of Recommendation Prof. Stypmann, January 2016
Letter_of_Recommendation_TBaal_from_Prof_Stypmann.pdf (299.77KB)

INOVATE-HF trial to support FDA approval of the CardioFit® active implantable vagus nerve stimulator for the treatment of heart failure:




Pilot Clinical Evaluation of the Zyga GLYDER Device to support CE approval of a novel implantable device for the treatment of chronic facetogenic pain:

“Dr. Baal was instrumental in assisting us gain positive approvals for clinical studies conducted in Europe. His knowledge of the clinical requirements and current regulatory environment complement his excellent communications skills. He is responsive, efficient, and is always a pleasure to work with. I highly recommend his services.”
(Diane Brinza, Director of Regulatory & Clinical Affairs, Zyga Technology, Inc., USA, www.zygatech.com; May 2011)
The GLYDER Device received CE mark on 18 Aug 2014

DEBuT-HT and Rheos® Pivotal clinical trials to support CE and FDA approval of a novel active implantable device for the treatment of resistant hypertension:

“I was extremely satisfied with Dr. Thomas Baal’s clinical trial knowledge and clinical trial support during the past four years. My colleagues and our study patients attribute Thomas’ collaborative and cooperative style to our success as a clinical trial site. Specifically, his in-depth medical and regulatory knowledge; willingness and commitment to promote the project; and his ability to optimize individual therapy for the patients were key elements to the success of the trial at our center.”
(Jan Menne, MD, Hypertension Specialist, Hannover Medical School, Germany; December 2009)

“During the past four years, Dr. Baal has been extremely valuable in supporting all surgical implant procedures of the Rheos® System. His technical assistance during the     mapping procedures and his guidance for the anaesthesiologists to comply with a non-standard 3-phase protocol were essential components for many successful implants.”
(Maximilian A. Pichlmaier, MD, Cardiovascular Surgeon, Hannover Medical School, Germany; December 2009)

Projects:

Project 11: Regulatory submissions of medical device clinical study projects to competent authorities and ethics committees for a contract research organisation (CRO).

  • Client: Medical device CRO, Germany.
  • Study: Medical device clinical trial projects.
  • Indications: Diabetes, gynaecology, intensive care.
  • Geographies: UK, Germany, Australia, Switzerland

Project 10: Regulatory submission and case coverage for a feasibility study to support 510(k) submission for market clearance.

  • Client: Manufacturer of a  robotic system for use in the remote delivery and manipulation of guide wires and balloon catheters in vascular interventions, Waltham, USA.
  • Study: RAPID trial: prospective, single center, single-arm, non-randomized 20 patients trial conducted in Austria.
  • Product: CorPath® 200 robotic system.
  • Indication: Peripheral artery disease.

Project 9: Regulatory submissions for a post market registry trial for clinical sites in Germany.

  • Client: Manufacturer of minimally invasive solutions for spine surgery, Minnetonka, USA.
  • Study: Glyder® Post Market Registry: prospective, multicenter, single-arm, 150 patients trial conducted in the EU.
  • Product: Minimal invasive permanent surgical implant.
  • Indication: Painful facet joint degeneration.

Project 8: Monitoring of 3 German centers participating in post marketing obstructive sleep apnea trial.

  • Client: Manufacturer of novel neurostimulation medical device for the treatment of Obstructive Sleep Apnea (OSA).
  • Study: prospective, multicenter, single-arm, 60 patient trial conducted in US and OUS.
  • Product: Programmable neurostimulator (Active Implantable Medical Device).
  • Indication: Obstructive Sleep Apnea (OSA).

Project 7: Regulatory submissions to German competent authorities and ethics committees for a multicenter pilot study to support FDA-approval.

  • Client: Manufacturer of minimally invasive solutions for spine surgery, Minnetonka, USA.
  •  Study: Glyder DUET Study: Prospective, open label, non-randomized,  20 patient trial conducted in Germany.
  • Product: Minimal invasive permanent surgical implant.
  • Indication: Painful facet joint degeneration.

Project 6: Site initiation, training and regulatory approval support of 5 clinical sites in Germany for a clinical trial to support CE-approval.

  • Client: US (California) based manufacturer of drug coated balloon catheters.
  • Study: One prospective, open label, randomized European multicenter pilot trial to support CE approval (360 patients).
  • Product: Drug eluting balloon catheters (for peripheral use).
  • Indication: Peripheral artery disease.

Project 5: Consultancy service for a strategic setup, organisation and design of two clinical trials to support CE-approval.

  • Client: Germany based leading designer and manufacturer of customized coatings for medical devices.
  • Studies: Two prospective, open label, randomized European multicenter pilot trials to support CE approval (100 patients each).
  • Products: Drug eluting balloon catheters (one for coronary, one for peripheral use).
  • Indication: Peripheral artery disease.

Project 4: Regulatory submissions to German competent authorities and ethics committees for a pilot study to support CE approval.

  • Client: German biotech company.
  • Study: ImmunoPAH: Prospective, open label, non-randomized German multicenter pilot study of 12 patients.
  •  Product: Immunoadsoption therapy system (class III product, using animal-derived tissue).
  • Indication: Idiopathic pulmonary arterial hypertension.

Project 3: Regulatory submissions to German ethics committees for an international multicenter post-market registry.

  • Client: Global leader in the science of heart valves, US headquarter.
  • Study: PREMIER: Prospective/retrospective, open label, non-randomized international, multicenter post-marked EMEA registry of 100 patients minimum.
  • Product: Transcatheter Heart Valve (THV).
  • Indication: Significant pulmonary valve regurgitation.

Project 2: Site Management and technical support for surgical implants and during patient follow ups in Europe.

  • Client: Israel/US based manufacturer of a programmable neurostimulator.
  • Study: INOVATE-HF: Prospective, open label, randomized multicenter, 650 patient pivotal study performed in the US and Europe to support FDA approval.
  • Product: Programmable neurostimulator (CardioFit®)(Active Implantable Medical Device).
  • Indication: Congestive Heart Failure.

Project 1: Regulatory submissions to German competent authorities and ethics committees for a multicenter pilot study to support CE-approval.

  • The GLYDER device received CE mark on 18 Aug 2014.
  • Client: Manufacturer of minimally invasive solutions for spine surgery, Minneapolis, USA.
  • Study: GLYDER-Study: Prospective, open label, nonrandomized, 40 patient pilot trial conducted in Germany and Brazil.
  • Product: Minimal invasive permanent surgical implant.
  • Indication: Painful facet joint degeneration.

 

Contact:

Dr. Thomas Baal
Erdmannstr. 2
10827 Berlin, Germany

Phone: +49-30-81494073
Cell: +49-160-94719910
email: tbaal(at)drbaal.de