FDA clears TransOral robotic surgery developed at Penn Medicine

Philadelphia 04 January 2010A minimally invasive surgical approach developed by head and neck surgeons at the University of Pennsylvania School of Medicine has been cleared by the United States Food and Drug Administration (FDA). The da Vinci Surgical System, developed by Intuitive Surgical Inc., Sunnyvale, California, has been cleared for TransOral otolaryngologic surgical procedures to treat benign tumours and select malignant tumours in adults.

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Drs. Gregory S. Weinstein and Bert W. O'Malley, Jr., of the University of Pennsylvania School of Medicine's Department of Otorhinolaryngology - Head and Neck Surgery, founded the world's first TransOral Robotic Surgery (TORS) programme at Penn Medicine in 2004, where they developed and researched the TORS approach for a variety of robotic surgical neck approaches for both malignant and benign tumours of the mouth, voice box, tonsil, tongue and other parts of the throat. Since 2005, approximately 350 Penn patients have participated in the world's first prospective clinical trials of TORS. These research trials compromise the largest and most comprehensive studies of the technology on record.

"TORS has dramatically improved the way we treat head and neck cancer patients, completely removing tumours while preserving speech, swallowing, and other key quality of life issues", stated Bert O'Malley, Jr., MD, professor and chairman of Penn Medicine's Department of Otorhinolaryngology - Head and Neck Surgery. "It is very exciting that a concept conceived at Penn, evaluated in pre-clinical experimental models at Penn, tested in clinical trials at Penn, and then taught to key surgeons and institutions both within the United States and internationally has been officially recognized by our federal governing agencies and peers around the world as a new and improved therapy for select neck cancers and all benign tumours."

45.000 Americans and approximately 500.000 people worldwide are diagnosed with head and neck cancers each year. Head and neck tumour treatments often involve a combination of surgery, radiation therapy, and chemotherapy. In many cases, surgery offers the greatest chance of cure; yet conventional surgery may require an almost ear-to-ear incision across the throat or splitting the jaw, resulting in speech and swallowing deficits for patients.

In comparison, the minimally invasive TORS approach, which accesses the surgical site through the mouth, has been shown to improve long term swallowing function and reduce risk of infection while speeding up the recovery time. When compared to traditional surgeries, after their cancers have been removed successfully, patients have been able to begin swallowing on their own sooner and leave the hospital earlier. TORS outcomes are markedly improved when compared to standard chemotherapy, radiation or traditional open surgical approaches for oropharyngeal cancer.

"Based on our data and patient outcomes, coupled with the national and international enthusiasm and interest for TORS, we are changing the way oropharyngeal cancer and tumours will be treated now and in years to come", noted Gregory Weinstein, MD, FACS, professor and vice chair of the University of Pennsylvania School of Medicine's Department of Otorhinolaryngology - Head and Neck Surgery, director of the Division of Head and Neck Surgery and current president of The Society of Robotic Surgery. "We are already investigating new TORS treatments for other conditions such as sleep apnea, and collaborating with colleagues in Penn Neurosurgery to use TORS to remove skull base tumors and repair cervical spine disease."

The Penn TORS programme developed an international training programme that has trained numerous surgical teams from 12 different countries, many of whom have started establishing TORS programmes at their respective institutions. With the FDA clearance of the da Vinci System for transoral otolaryngology, Penn Medicine will immediately expand its well established training programme to include surgical teams from the United States.

Drs. Weinstein and O'Malley have no financial ties or consulting agreement with the surgical company. Penn Medicine is one of the world's leading academic medical centres, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the University of Pennsylvania School of Medicine - founded in 1765 as the United States' first medical school - and the University of Pennsylvania Health System, which together form a $3,6 billion enterprise.

Penn's School of Medicine is currently ranked number 3 in U.S. News & World Report's survey of research-oriented medical schools, and is consistently among the United States' top recipients of funding from the National Institutes of Health, with $367,2 million awarded in the 2008 fiscal year.

Penn Medicine's patient care facilities include:

  • The Hospital of the University of Pennsylvania - the United States' first teaching hospital, recognized as one of the nation's top 10 hospitals by U.S. News & World Report.
  • Penn Presbyterian Medical Center - named one of the top 100 hospitals for cardiovascular care by Thomson Reuters for six years.
  • Pennsylvania Hospital - the United States' first hospital, founded in 1751, nationally recognized for excellence in orthopaedics, obstetrics & gynaecology, and behavioural health.

Additional patient care facilities and services include Penn Medicine at Rittenhouse, a Philadelphia campus offering inpatient rehabilitation and outpatient care in many specialties; as well as a primary care provider network; a faculty practice plan; home care and hospice services; and several multispecialty outpatient facilities across the Philadelphia region. Penn Medicine is committed to improving lives and health through a variety of community-based programmes and activities. In fiscal year 2008, Penn Medicine provided $282 million to benefit the community.

You can find more information about the Penn TORS programme at the University of Pennsylvania School of Medicine's Department of Otorhinolaryngology - Head and Neck Surgery website and in the VMW June 2005 article Robotic surgery dramatically reduces physical trauma for head and neck cancer patients.


Source: University of Pennsylvania School of Medicine

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